Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-16 @ 5:24 PM
Study NCT ID:
NCT00272961
Status:
TERMINATED
Last Update Posted:
2013-03-05
First Post:
2006-01-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C485107', 'term': 'N-(2-acetyl-4,6-dimethylphenyl)-3-(3,4-dimethylisoxazol-5-ylsulfamoyl)thiophene-2-carboxamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Results for 'change from standing to sitting SBP and DBP' and 'change from pre-dose to post-dose SBP and DBP' are reported only at Week 10 as per changes in planned analysis because of early termination of the study and clinical development program."}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Blood Pressure (BP) Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Sitting SBP (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '11.48', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '4.67', 'groupId': 'OG001'}, {'value': '11.26', 'spread': '3.83', 'groupId': 'OG002'}, {'value': '11.52', 'spread': '4.03', 'groupId': 'OG003'}, {'value': '10.46', 'spread': '4.09', 'groupId': 'OG004'}]}]}, {'title': 'Standing SBP (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '9.06', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '8.38', 'spread': '3.08', 'groupId': 'OG002'}, {'value': '9.63', 'spread': '3.23', 'groupId': 'OG003'}, {'value': '14.76', 'spread': '3.23', 'groupId': 'OG004'}]}]}, {'title': 'Sitting DBP (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '8.16', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '6.73', 'spread': '1.65', 'groupId': 'OG002'}, {'value': '1.79', 'spread': '1.77', 'groupId': 'OG003'}, {'value': '7.17', 'spread': '1.81', 'groupId': 'OG004'}]}]}, {'title': 'Standing DBP (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '7.91', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '7.11', 'spread': '1.62', 'groupId': 'OG002'}, {'value': '2.27', 'spread': '1.69', 'groupId': 'OG003'}, {'value': '6.25', 'spread': '1.74', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.37', 'ciLowerLimit': '-4.21', 'ciUpperLimit': '20.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.19', 'groupDescription': 'Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.970', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-11.16', 'ciUpperLimit': '11.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.59', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.994', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-11.66', 'ciUpperLimit': '11.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.71', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.861', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '-10.62', 'ciUpperLimit': '12.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.72', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.10', 'ciLowerLimit': '-3.79', 'ciUpperLimit': '15.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.90', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.880', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-8.37', 'ciUpperLimit': '9.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.49', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.900', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-9.78', 'ciUpperLimit': '8.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.56', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.71', 'ciLowerLimit': '-14.91', 'ciUpperLimit': '3.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.56', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.62', 'ciLowerLimit': '0.17', 'ciUpperLimit': '11.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.68', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.557', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '6.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.41', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.37', 'ciLowerLimit': '1.28', 'ciUpperLimit': '11.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.695', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '6.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.50', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.80', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '9.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.737', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '-3.96', 'ciUpperLimit': '5.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.36', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.64', 'ciLowerLimit': '0.80', 'ciUpperLimit': '10.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.40', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.495', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '6.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.40', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12', 'description': 'BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants evaluable for specified category for each treatment arm, respectively.'}, {'type': 'PRIMARY', 'title': 'Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Sitting SBP (n= 8, 5, 9, 8, 8)', 'categories': [{'measurements': [{'value': '318.50', 'spread': '125.20', 'groupId': 'OG000'}, {'value': '85.91', 'spread': '158.59', 'groupId': 'OG001'}, {'value': '214.83', 'spread': '119.85', 'groupId': 'OG002'}, {'value': '277.24', 'spread': '125.27', 'groupId': 'OG003'}, {'value': '152.10', 'spread': '126.57', 'groupId': 'OG004'}]}]}, {'title': 'Standing SBP (n= 10, 7, 11, 10, 10)', 'categories': [{'measurements': [{'value': '237.83', 'spread': '83.52', 'groupId': 'OG000'}, {'value': '74.79', 'spread': '99.66', 'groupId': 'OG001'}, {'value': '122.48', 'spread': '79.95', 'groupId': 'OG002'}, {'value': '213.16', 'spread': '83.46', 'groupId': 'OG003'}, {'value': '187.24', 'spread': '83.37', 'groupId': 'OG004'}]}]}, {'title': 'Sitting DBP (n= 8, 5, 9, 8, 8)', 'categories': [{'measurements': [{'value': '256.38', 'spread': '67.58', 'groupId': 'OG000'}, {'value': '30.82', 'spread': '85.41', 'groupId': 'OG001'}, {'value': '141.61', 'spread': '63.97', 'groupId': 'OG002'}, {'value': '31.50', 'spread': '68.88', 'groupId': 'OG003'}, {'value': '123.17', 'spread': '70.03', 'groupId': 'OG004'}]}]}, {'title': 'Standing DBP (n= 10, 7, 11, 10, 10)', 'categories': [{'measurements': [{'value': '282.89', 'spread': '73.31', 'groupId': 'OG000'}, {'value': '42.26', 'spread': '87.57', 'groupId': 'OG001'}, {'value': '124.90', 'spread': '70.65', 'groupId': 'OG002'}, {'value': '27.99', 'spread': '73.46', 'groupId': 'OG003'}, {'value': '125.23', 'spread': '75.08', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '232.59', 'ciLowerLimit': '-178.5', 'ciUpperLimit': '643.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '201.83', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5552', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '103.67', 'ciLowerLimit': '-250.5', 'ciUpperLimit': '457.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '173.86', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8174', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.26', 'ciLowerLimit': '-319.8', 'ciUpperLimit': '402.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '177.26', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3557', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '166.40', 'ciLowerLimit': '-195.3', 'ciUpperLimit': '528.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '177.55', 'groupDescription': 'Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '163.04', 'ciLowerLimit': '-99.6', 'ciUpperLimit': '425.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '130.15', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3258', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '115.35', 'ciLowerLimit': '-118.8', 'ciUpperLimit': '349.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '116.03', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8352', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.67', 'ciLowerLimit': '-213.2', 'ciUpperLimit': '262.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '117.88', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6701', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.59', 'ciLowerLimit': '-187.4', 'ciUpperLimit': '288.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '117.93', 'groupDescription': 'Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '225.57', 'ciLowerLimit': '3.6', 'ciUpperLimit': '447.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '108.95', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2274', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '114.77', 'ciLowerLimit': '-75.2', 'ciUpperLimit': '304.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '93.2637', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0269', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '224.89', 'ciLowerLimit': '27.5', 'ciUpperLimit': '422.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '96.9259', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1780', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '133.22', 'ciLowerLimit': '-63.8', 'ciUpperLimit': '330.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '96.7383', 'groupDescription': 'Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '240.64', 'ciLowerLimit': '9.9', 'ciUpperLimit': '471.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '114.32', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1297', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '157.99', 'ciLowerLimit': '-48.3', 'ciUpperLimit': '364.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '102.21', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0185', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '254.90', 'ciLowerLimit': '45.0', 'ciUpperLimit': '464.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '104.00', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1382', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '157.66', 'ciLowerLimit': '-52.9', 'ciUpperLimit': '368.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '104.33', 'groupDescription': 'Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12', 'description': 'AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received at least 1 dose of study treatment. "N"(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Sitting Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Baseline: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '158.6', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '149.9', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '146.5', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '151.1', 'spread': '3.2', 'groupId': 'OG003'}, {'value': '158.4', 'spread': '5.8', 'groupId': 'OG004'}]}]}, {'title': 'Baseline: Post-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '149.9', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '141', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '139.7', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '149.3', 'spread': '4.4', 'groupId': 'OG003'}, {'value': '148.8', 'spread': '6.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '156.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '151', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '143.5', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '145.3', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '154.9', 'spread': '4.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Post-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '151.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '141.1', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '134.4', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '139.4', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '143.6', 'spread': '7.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '149.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '144.7', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '143.5', 'spread': '5.8', 'groupId': 'OG002'}, {'value': '147.1', 'spread': '4.4', 'groupId': 'OG003'}, {'value': '153.1', 'spread': '4.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Post-Dose (n= 8, 6, 9, 8, 7)', 'categories': [{'measurements': [{'value': '139.8', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '130.6', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '134.7', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '139', 'spread': '4.7', 'groupId': 'OG003'}, {'value': '134.3', 'spread': '6.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Pre-Dose (n= 8, 4, 7, 7, 8)', 'categories': [{'measurements': [{'value': '148', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '141.5', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '137.1', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '142', 'spread': '5.2', 'groupId': 'OG003'}, {'value': '141.8', 'spread': '6.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Post-Dose (n= 8, 5, 6, 7, 8)', 'categories': [{'measurements': [{'value': '144.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '138.1', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '123.2', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '138.5', 'spread': '6.0', 'groupId': 'OG003'}, {'value': '130.3', 'spread': '7.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Pre-Dose (n= 7, 5, 8, 8, 8)', 'categories': [{'measurements': [{'value': '141.4', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '141.2', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '140.9', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '135.8', 'spread': '3.7', 'groupId': 'OG003'}, {'value': '140.8', 'spread': '6.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Post-Dose (n= 7, 4, 8, 7, 8)', 'categories': [{'measurements': [{'value': '143', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '137', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '132.2', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '132.3', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '132.8', 'spread': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Pre-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '149.2', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '140.9', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '131.7', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '137.9', 'spread': '7.8', 'groupId': 'OG003'}, {'value': '137.9', 'spread': '4.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Post-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '141.7', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '130.9', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '124.4', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '132.7', 'spread': '5.7', 'groupId': 'OG003'}, {'value': '135.3', 'spread': '8.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Pre-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '139.6', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '143.2', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '126.4', 'spread': '4.4', 'groupId': 'OG002'}, {'value': '141.7', 'spread': '6.9', 'groupId': 'OG003'}, {'value': '138.3', 'spread': '5.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Post-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '132.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '136.8', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '122.8', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '136.6', 'spread': '5.2', 'groupId': 'OG003'}, {'value': '125.9', 'spread': '9.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Pre-Dose (n= 7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '142.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '148.3', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '134.5', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '136.8', 'spread': '5.8', 'groupId': 'OG003'}, {'value': '141.6', 'spread': '6.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose (n= 7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '134.1', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '142', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '131.3', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '131.7', 'spread': '6.8', 'groupId': 'OG003'}, {'value': '132.8', 'spread': '7.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent \\[%\\] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Standing Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Baseline: Pre-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '153.6', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '147.7', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '147.3', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '153.8', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '154.1', 'spread': '4.8', 'groupId': 'OG004'}]}]}, {'title': 'Baseline: Post-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '146.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '141.9', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '142.4', 'spread': '4.4', 'groupId': 'OG002'}, {'value': '149.5', 'spread': '4.7', 'groupId': 'OG003'}, {'value': '147', 'spread': '5.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Pre-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '151.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '147.3', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '145.7', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '146.8', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '154.3', 'spread': '4.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Post-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '147.8', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '139.4', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '139.2', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '141.4', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '144.8', 'spread': '6.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Pre-Dose (n= 10, 8, 11, 10, 9)', 'categories': [{'measurements': [{'value': '151.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '142.8', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '145.8', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '150.7', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '149.7', 'spread': '5.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Post-Dose (n= 10, 8, 11, 10, 9)', 'categories': [{'measurements': [{'value': '140.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '130.8', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '138.3', 'spread': '7.3', 'groupId': 'OG002'}, {'value': '142.9', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '135.8', 'spread': '6.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Pre-Dose (n= 10, 6, 8, 8, 10)', 'categories': [{'measurements': [{'value': '146.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '140.9', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '136.8', 'spread': '5.8', 'groupId': 'OG002'}, {'value': '147.3', 'spread': '7.1', 'groupId': 'OG003'}, {'value': '141.2', 'spread': '6.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Post-Dose (n= 10, 7, 7, 8, 10)', 'categories': [{'measurements': [{'value': '142.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '137.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '124.9', 'spread': '6.4', 'groupId': 'OG002'}, {'value': '143.1', 'spread': '7.6', 'groupId': 'OG003'}, {'value': '128.6', 'spread': '7.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Pre-Dose (n= 9, 7, 9, 9, 10)', 'categories': [{'measurements': [{'value': '141.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '139.6', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '141.5', 'spread': '5.8', 'groupId': 'OG002'}, {'value': '137.4', 'spread': '5.7', 'groupId': 'OG003'}, {'value': '139.5', 'spread': '6.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Post-Dose (n= 9, 6, 9, 8, 10)', 'categories': [{'measurements': [{'value': '141', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '133.4', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '132.6', 'spread': '7.7', 'groupId': 'OG002'}, {'value': '132.6', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '129.5', 'spread': '9.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Pre-Dose (n= 9, 7, 8, 8, 8)', 'categories': [{'measurements': [{'value': '145.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '138.2', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '131.3', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '138.9', 'spread': '8.2', 'groupId': 'OG003'}, {'value': '134.1', 'spread': '4.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Post-Dose (n= 9, 7, 8, 8, 8)', 'categories': [{'measurements': [{'value': '139.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '130.5', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '122.8', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '130.6', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '127.9', 'spread': '7.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Pre-Dose (n= 8, 6, 8, 8, 7)', 'categories': [{'measurements': [{'value': '139.2', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '143.2', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '125.9', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '141.5', 'spread': '6.0', 'groupId': 'OG003'}, {'value': '135.5', 'spread': '6.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Post-Dose (n= 8, 6, 8, 8, 7)', 'categories': [{'measurements': [{'value': '131.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '138.6', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '124.1', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '139.3', 'spread': '7.4', 'groupId': 'OG003'}, {'value': '123.3', 'spread': '9.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Pre-Dose (n= 8, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '141.1', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '147', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '133.4', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '137.6', 'spread': '6.7', 'groupId': 'OG003'}, {'value': '141', 'spread': '7.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose (n= 8, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '133.5', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '141.2', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '131', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '133.5', 'spread': '8.9', 'groupId': 'OG003'}, {'value': '128.9', 'spread': '8.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Sitting Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Baseline: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '95.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '87', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '87.3', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '87.8', 'spread': '3.5', 'groupId': 'OG003'}, {'value': '99.3', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline: Post-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '91.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '81', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '82.4', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '82.7', 'spread': '3.8', 'groupId': 'OG003'}, {'value': '93.7', 'spread': '3.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '92.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '88.4', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '87.5', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '83.6', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '99.3', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Post-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '89.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '80', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '77.6', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '94.4', 'spread': '3.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Pre-Dose (n= 8, 6, 9, 8, 8)', 'categories': [{'measurements': [{'value': '90.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '86.1', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '87.1', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '84.4', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '96.3', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Post-Dose (n= 8, 6, 9, 8, 7)', 'categories': [{'measurements': [{'value': '83.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '71.8', 'spread': '3.4', 'groupId': 'OG003'}, {'value': '83.7', 'spread': '4.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Pre-Dose (n= 8, 4, 7, 7, 8)', 'categories': [{'measurements': [{'value': '89.3', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '86', 'spread': '6.7', 'groupId': 'OG002'}, {'value': '79.8', 'spread': '7.1', 'groupId': 'OG003'}, {'value': '91.6', 'spread': '1.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Post-Dose (n= 8, 5, 6, 7, 8)', 'categories': [{'measurements': [{'value': '87.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '74.9', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '72.8', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '71.8', 'spread': '6.1', 'groupId': 'OG003'}, {'value': '79.9', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Pre-Dose (n= 7, 5, 8, 8, 8)', 'categories': [{'measurements': [{'value': '83.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '79.2', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '86', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '78.1', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '89.3', 'spread': '3.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Post-Dose (n= 7, 4, 8, 7, 8)', 'categories': [{'measurements': [{'value': '82', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '76.6', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '68.6', 'spread': '3.7', 'groupId': 'OG003'}, {'value': '81', 'spread': '4.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Pre-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '86.8', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '78.3', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '80.7', 'spread': '5.2', 'groupId': 'OG003'}, {'value': '92.1', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Post-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '84.1', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '68.9', 'spread': '3.5', 'groupId': 'OG003'}, {'value': '84.7', 'spread': '5.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Pre-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '84.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '82.9', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '79.3', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '80.6', 'spread': '5.7', 'groupId': 'OG003'}, {'value': '93.7', 'spread': '3.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Post-Dose (n= 7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '78.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '76.1', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '73.7', 'spread': '5.5', 'groupId': 'OG003'}, {'value': '83.8', 'spread': '6.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Pre-Dose (n= 7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '87.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '85.5', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '84.8', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '79.1', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '93', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose (n= 7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '79.9', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '81.3', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '66.8', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '85.4', 'spread': '4.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Standing Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Baseline: Pre-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '95.9', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '89', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '87.9', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '90.3', 'spread': '2.9', 'groupId': 'OG003'}, {'value': '97.7', 'spread': '2.8', 'groupId': 'OG004'}]}]}, {'title': 'Baseline: Post-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '92.3', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '85', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '83.1', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '85.1', 'spread': '3.3', 'groupId': 'OG003'}, {'value': '95.5', 'spread': '2.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Pre-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '95.1', 'spread': '5', 'groupId': 'OG000'}, {'value': '90.3', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '88.7', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '87.2', 'spread': '4.0', 'groupId': 'OG003'}, {'value': '98.9', 'spread': '1.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: Post-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '91.5', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '81.3', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '82.7', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '81.4', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '93.7', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Pre-Dose (n= 10, 8, 11, 10, 10)', 'categories': [{'measurements': [{'value': '92.7', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '87.7', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '87.9', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '89.5', 'spread': '3.7', 'groupId': 'OG003'}, {'value': '96.9', 'spread': '2.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: Post-Dose (n= 10, 8, 11, 10, 9)', 'categories': [{'measurements': [{'value': '87.3', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '80.8', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '77.1', 'spread': '3.2', 'groupId': 'OG003'}, {'value': '84.8', 'spread': '4.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Pre-Dose (n= 10, 6, 8, 8, 10)', 'categories': [{'measurements': [{'value': '91.9', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '86', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '85.7', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '84.5', 'spread': '6.5', 'groupId': 'OG003'}, {'value': '91.8', 'spread': '2.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 3: Post-Dose (n= 10, 7, 7, 8, 10)', 'categories': [{'measurements': [{'value': '90', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '75.7', 'spread': '4.8', 'groupId': 'OG002'}, {'value': '78.6', 'spread': '6.4', 'groupId': 'OG003'}, {'value': '80.7', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Pre-Dose (n= 9, 7, 9, 9, 10)', 'categories': [{'measurements': [{'value': '86.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '85.9', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '81.2', 'spread': '4.0', 'groupId': 'OG003'}, {'value': '88.9', 'spread': '3.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4: Post-Dose (n= 9, 6, 9, 8, 10)', 'categories': [{'measurements': [{'value': '85.9', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '71.6', 'spread': '2.8', 'groupId': 'OG003'}, {'value': '83.1', 'spread': '3.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Pre-Dose (n= 9, 7, 8, 8, 8)', 'categories': [{'measurements': [{'value': '87.9', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '81.6', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '81.6', 'spread': '4.7', 'groupId': 'OG003'}, {'value': '91.3', 'spread': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 6: Post-Dose (n= 9, 7, 8, 8, 8)', 'categories': [{'measurements': [{'value': '85.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '74.4', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '70.1', 'spread': '3.4', 'groupId': 'OG003'}, {'value': '83.3', 'spread': '3.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Pre-Dose (n= 8, 6, 8, 8, 7)', 'categories': [{'measurements': [{'value': '87.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '79.8', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '83.7', 'spread': '4.9', 'groupId': 'OG003'}, {'value': '92', 'spread': '4.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Post-Dose (n= 8, 6, 8, 8, 7)', 'categories': [{'measurements': [{'value': '81.1', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '75.4', 'spread': '4.4', 'groupId': 'OG002'}, {'value': '75.3', 'spread': '5.0', 'groupId': 'OG003'}, {'value': '84.5', 'spread': '5.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Pre-Dose (n= 8, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '88.7', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '86.2', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '80.3', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '93.4', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose (n= 8, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '83.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '73.8', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '81.3', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '67', 'spread': '3.7', 'groupId': 'OG003'}, {'value': '84.2', 'spread': '4.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Week 10: Pre-Dose', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '1.74', 'groupId': 'OG003'}, {'value': '-0.85', 'spread': '2.01', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose', 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '1.28', 'spread': '1.95', 'groupId': 'OG002'}, {'value': '-1.30', 'spread': '1.93', 'groupId': 'OG003'}, {'value': '1.66', 'spread': '2.22', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '-5.31', 'ciUpperLimit': '7.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.00', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8880', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-5.40', 'ciUpperLimit': '4.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.45', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4573', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '-3.21', 'ciUpperLimit': '6.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.46', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4424', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '-3.56', 'ciUpperLimit': '7.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.78', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3470', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.18', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '10.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.32', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6249', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '-4.25', 'ciUpperLimit': '6.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.72', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1625', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '9.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.73', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7556', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '-5.38', 'ciUpperLimit': '7.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Week 10: Pre-Dose', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '-1.42', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-1.18', 'spread': '0.98', 'groupId': 'OG003'}, {'value': '-0.43', 'spread': '1.03', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Post-Dose', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '0.68', 'spread': '1.36', 'groupId': 'OG003'}, {'value': '0.80', 'spread': '1.43', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.99', 'ciLowerLimit': '-6.25', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.59', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7269', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '3.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.34', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8656', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '3.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7113', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '2.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.40', 'groupDescription': 'Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2204', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.77', 'ciLowerLimit': '-7.32', 'ciUpperLimit': '1.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.21', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5298', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-5.04', 'ciUpperLimit': '2.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3135', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '1.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2962', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.08', 'ciLowerLimit': '-6.09', 'ciUpperLimit': '1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.95', 'groupDescription': 'Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Week 10: Sitting', 'categories': [{'measurements': [{'value': '-8.33', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '-4.59', 'spread': '4.30', 'groupId': 'OG001'}, {'value': '-4.49', 'spread': '3.25', 'groupId': 'OG002'}, {'value': '-5.87', 'spread': '3.23', 'groupId': 'OG003'}, {'value': '-7.03', 'spread': '3.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Standing', 'categories': [{'measurements': [{'value': '-7.34', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-4.41', 'spread': '4.19', 'groupId': 'OG001'}, {'value': '-3.13', 'spread': '3.16', 'groupId': 'OG002'}, {'value': '-5.24', 'spread': '3.17', 'groupId': 'OG003'}, {'value': '-11.17', 'spread': '3.42', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4933', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.74', 'ciLowerLimit': '-14.84', 'ciUpperLimit': '7.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.39', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4080', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.85', 'ciLowerLimit': '-13.26', 'ciUpperLimit': '5.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.57', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5936', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.47', 'ciLowerLimit': '-11.86', 'ciUpperLimit': '6.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.56', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7883', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-11.17', 'ciUpperLimit': '8.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.79', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5719', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.93', 'ciLowerLimit': '-13.46', 'ciUpperLimit': '7.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.12', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3401', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.21', 'ciLowerLimit': '-13.11', 'ciUpperLimit': '4.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.33', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6329', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-11.01', 'ciUpperLimit': '6.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.34', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4037', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.83', 'ciLowerLimit': '-5.45', 'ciUpperLimit': '13.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.51', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'OG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'OG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'OG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'classes': [{'title': 'Week 10: Sitting', 'categories': [{'measurements': [{'value': '-8.57', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-9.79', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '-3.69', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '-11.28', 'spread': '2.52', 'groupId': 'OG003'}, {'value': '-7.23', 'spread': '2.66', 'groupId': 'OG004'}]}]}, {'title': 'Week 10: Standing', 'categories': [{'measurements': [{'value': '-6.90', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-10.35', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '-5.51', 'spread': '2.55', 'groupId': 'OG002'}, {'value': '-11.67', 'spread': '2.61', 'groupId': 'OG003'}, {'value': '-7.97', 'spread': '2.78', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '-7.19', 'ciUpperLimit': '9.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.08', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1739', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.88', 'ciLowerLimit': '-12.07', 'ciUpperLimit': '2.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.49', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4612', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '-4.74', 'ciUpperLimit': '10.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.61', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7172', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-8.90', 'ciUpperLimit': '6.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.67', 'groupDescription': 'Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.45', 'ciLowerLimit': '-5.01', 'ciUpperLimit': '11.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.12', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6943', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-8.54', 'ciUpperLimit': '5.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.48', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2042', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.78', 'ciLowerLimit': '-2.76', 'ciUpperLimit': '12.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.67', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7791', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '-6.69', 'ciUpperLimit': '8.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.77', 'groupDescription': 'Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'FG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'FG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'FG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'FG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}], 'periods': [{'title': 'Placebo Run-in Phase: Up to Week 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subject Defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant Needed Prohibited Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: Week 3 Up to Week 12', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Participant Defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.'}, {'id': 'BG001', 'title': 'TBC3711 10 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'BG002', 'title': 'TBC3711 50 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.'}, {'id': 'BG003', 'title': 'TBC3711 100 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.'}, {'id': 'BG004', 'title': 'TBC3711 200 mg', 'description': 'Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': '45 to 64 Years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}]}]}, {'title': 'Greater Than or Equal to (>=) 65 Years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2012-01-26', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2006-01-04', 'dispFirstSubmitQcDate': '2012-08-23', 'resultsFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2006-01-04', 'dispFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-28', 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Blood Pressure (BP) Increase', 'timeFrame': 'Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12', 'description': 'BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.'}, {'measure': 'Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change', 'timeFrame': 'Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12', 'description': 'AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.'}], 'secondaryOutcomes': [{'measure': 'Sitting Systolic Blood Pressure (SBP)', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent \\[%\\] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study."}, {'measure': 'Standing Systolic Blood Pressure (SBP)', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study."}, {'measure': 'Sitting Diastolic Blood Pressure (DBP)', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study."}, {'measure': 'Standing Diastolic Blood Pressure (DBP)', 'timeFrame': 'Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study."}, {'measure': 'Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study."}, {'measure': 'Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study."}, {'measure': 'Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study."}, {'measure': 'Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10', 'timeFrame': 'Pre-Dose and 2 hours Post-Dose on Week 10', 'description': "DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Resistant Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1341001&StudyName=A%20study%20of%20different%20doses%20of%20TBC3711%20in%20patients%20with%20uncontolled%20high%20blood%20pressure%20already%20taking%20medications%20for%20high%20blood%20press', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.', 'detailedDescription': 'The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of resistant hypertension.\n* A stable anti-hypertensive drug regimen for at least 30 days.\n\nExclusion Criteria:\n\n* Sustained blood pressure greater than or equal to 180/120 mmHg.\n* Required use of thigh cuff for blood pressure readings.\n* Uncontrolled diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT00272961', 'briefTitle': 'A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension', 'orgStudyIdInfo': {'id': 'B1341001'}, 'secondaryIdInfos': [{'id': 'GRH01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 1', 'interventionNames': ['Drug: TBC3711']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 2', 'interventionNames': ['Drug: TBC3711']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 3', 'interventionNames': ['Drug: TBC3711']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 4', 'interventionNames': ['Drug: TBC3711']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo tablet once daily for 12 weeks', 'armGroupLabels': ['placebo']}, {'name': 'TBC3711', 'type': 'DRUG', 'description': '10 mg tablets once daily for 10 weeks', 'armGroupLabels': ['ARM 1']}, {'name': 'TBC3711', 'type': 'DRUG', 'description': '50 mg tablet once daily for 10 weeks', 'armGroupLabels': ['ARM 2']}, {'name': 'TBC3711', 'type': 'DRUG', 'description': '100 mg tablet once daily for 10 weeks', 'armGroupLabels': ['ARM 3']}, {'name': 'TBC3711', 'type': 'DRUG', 'description': '200 mg tablet once daily for 10 weeks', 'armGroupLabels': ['ARM 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-2041', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30904', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '73132-4904', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '75006', 'city': 'Carroltown', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site'}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}