Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-04-19 @ 12:18 AM
Study NCT ID:
NCT00347360
Status:
COMPLETED
Last Update Posted:
2016-12-26
First Post:
2006-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the Publication of results from all centers of a multi-center trial but requests that reports based on Single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).', 'eventGroups': [{'id': 'EG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily', 'otherNumAffected': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily', 'otherNumAffected': 15, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily', 'otherNumAffected': 21, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily', 'otherNumAffected': 20, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily', 'otherNumAffected': 17, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily', 'otherNumAffected': 13, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily', 'otherNumAffected': 19, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily', 'otherNumAffected': 20, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily', 'otherNumAffected': 30, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily', 'otherNumAffected': 21, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily', 'otherNumAffected': 33, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily', 'otherNumAffected': 19, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily', 'otherNumAffected': 13, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily', 'otherNumAffected': 38, 'seriousNumAffected': 1}, {'id': 'EG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily', 'otherNumAffected': 15, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG009', 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'EG014', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.79', 'spread': '5.922', 'groupId': 'OG000'}, {'value': '-8.11', 'spread': '8.811', 'groupId': 'OG001'}, {'value': '-7.37', 'spread': '5.914', 'groupId': 'OG002'}, {'value': '-4.40', 'spread': '5.182', 'groupId': 'OG003'}, {'value': '-7.61', 'spread': '4.880', 'groupId': 'OG004'}, {'value': '-6.52', 'spread': '6.408', 'groupId': 'OG005'}, {'value': '-9.29', 'spread': '7.226', 'groupId': 'OG006'}, {'value': '-8.57', 'spread': '6.585', 'groupId': 'OG007'}, {'value': '-10.19', 'spread': '6.899', 'groupId': 'OG008'}, {'value': '-9.36', 'spread': '7.426', 'groupId': 'OG009'}, {'value': '-10.96', 'spread': '8.388', 'groupId': 'OG010'}, {'value': '-10.37', 'spread': '7.234', 'groupId': 'OG011'}, {'value': '-10.93', 'spread': '5.517', 'groupId': 'OG012'}, {'value': '-11.09', 'spread': '8.719', 'groupId': 'OG013'}, {'value': '-11.92', 'spread': '6.887', 'groupId': 'OG014'}]}]}], 'analyses': [{'pValue': '>0.1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011', 'OG012', 'OG013', 'OG014'], 'ciPctValue': '95', 'groupDescription': 'This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.', 'statisticalMethod': 'Hung AVE test, see comments', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6.', 'description': 'Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in Trough Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '33', 'groupId': 'OG010'}, {'value': '33', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.40', 'spread': '7.982', 'groupId': 'OG000'}, {'value': '-6.08', 'spread': '8.735', 'groupId': 'OG001'}, {'value': '-8.16', 'spread': '7.299', 'groupId': 'OG002'}, {'value': '-2.34', 'spread': '7.060', 'groupId': 'OG003'}, {'value': '-7.76', 'spread': '8.285', 'groupId': 'OG004'}, {'value': '-5.26', 'spread': '9.530', 'groupId': 'OG005'}, {'value': '-5.14', 'spread': '7.002', 'groupId': 'OG006'}, {'value': '-6.36', 'spread': '9.080', 'groupId': 'OG007'}, {'value': '-7.22', 'spread': '11.284', 'groupId': 'OG008'}, {'value': '-6.79', 'spread': '9.210', 'groupId': 'OG009'}, {'value': '-7.76', 'spread': '11.202', 'groupId': 'OG010'}, {'value': '-4.90', 'spread': '8.508', 'groupId': 'OG011'}, {'value': '-6.54', 'spread': '8.305', 'groupId': 'OG012'}, {'value': '-7.26', 'spread': '9.345', 'groupId': 'OG013'}, {'value': '-8.42', 'spread': '7.903', 'groupId': 'OG014'}]}]}], 'analyses': [{'pValue': '>0.1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011', 'OG012', 'OG013', 'OG014'], 'ciPctValue': '95', 'groupDescription': 'This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.', 'statisticalMethod': 'Hung AVE test, see comments', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough ABPM was the average across 20-24 hr after dosing for each subject.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. 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The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Trough Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '33', 'groupId': 'OG010'}, {'value': '33', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.47', 'spread': '13.301', 'groupId': 'OG000'}, {'value': '-7.52', 'spread': '12.221', 'groupId': 'OG001'}, {'value': '-9.54', 'spread': '9.968', 'groupId': 'OG002'}, {'value': '-0.96', 'spread': '11.447', 'groupId': 'OG003'}, {'value': '-9.27', 'spread': '12.362', 'groupId': 'OG004'}, {'value': '-5.68', 'spread': '14.539', 'groupId': 'OG005'}, {'value': '-6.44', 'spread': '9.739', 'groupId': 'OG006'}, {'value': '-9.27', 'spread': '13.582', 'groupId': 'OG007'}, {'value': '-9.88', 'spread': '14.356', 'groupId': 'OG008'}, {'value': '-8.87', 'spread': '11.954', 'groupId': 'OG009'}, {'value': '-8.11', 'spread': '13.732', 'groupId': 'OG010'}, {'value': '-5.82', 'spread': '13.878', 'groupId': 'OG011'}, {'value': '-9.80', 'spread': '11.196', 'groupId': 'OG012'}, {'value': '-10.74', 'spread': '12.813', 'groupId': 'OG013'}, {'value': '-10.00', 'spread': '12.091', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough ABPM was the average across 20-24 hr after dosing for each subject.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.77', 'spread': '0.821', 'groupId': 'OG000'}, {'value': '-7.55', 'spread': '0.717', 'groupId': 'OG001'}, {'value': '-7.49', 'spread': '0.877', 'groupId': 'OG002'}, {'value': '-5.11', 'spread': '0.821', 'groupId': 'OG003'}, {'value': '-6.61', 'spread': '0.718', 'groupId': 'OG004'}, {'value': '-7.13', 'spread': '0.925', 'groupId': 'OG005'}, {'value': '-8.08', 'spread': '0.472', 'groupId': 'OG006'}, {'value': '-9.83', 'spread': '0.536', 'groupId': 'OG007'}, {'value': '-9.71', 'spread': '0.657', 'groupId': 'OG008'}, {'value': '-9.55', 'spread': '0.534', 'groupId': 'OG009'}, {'value': '-11.3', 'spread': '0.645', 'groupId': 'OG010'}, {'value': '-11.1', 'spread': '0.702', 'groupId': 'OG011'}, {'value': '-10.0', 'spread': '0.696', 'groupId': 'OG012'}, {'value': '-11.7', 'spread': '0.722', 'groupId': 'OG013'}, {'value': '-11.4', 'spread': '1.042', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '33', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '133.33', 'groupId': 'OG000'}, {'value': '61.04', 'groupId': 'OG001'}, {'value': '114.45', 'groupId': 'OG002'}, {'value': '34.11', 'groupId': 'OG003'}, {'value': '71.00', 'groupId': 'OG004'}, {'value': '49.67', 'groupId': 'OG005'}, {'value': '44.50', 'groupId': 'OG006'}, {'value': '49.46', 'groupId': 'OG007'}, {'value': '59.47', 'groupId': 'OG008'}, {'value': '54.71', 'groupId': 'OG009'}, {'value': '52.86', 'groupId': 'OG010'}, {'value': '37.93', 'groupId': 'OG011'}, {'value': '41.95', 'groupId': 'OG012'}, {'value': '53.54', 'groupId': 'OG013'}, {'value': '52.07', 'groupId': 'OG014'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak \\> 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.', 'unitOfMeasure': 'trough:peak ratio x 100%', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.', 'timeFrame': 'Weeks 1 through 48', 'description': 'Refer to Adverse Event section for safety information.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'title': 'Change in Morning SBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-9.37', 'spread': '9.564', 'groupId': 'OG000'}, {'value': '-14.53', 'spread': '17.166', 'groupId': 'OG001'}, {'value': '-10.76', 'spread': '9.112', 'groupId': 'OG002'}, {'value': '-6.23', 'spread': '9.159', 'groupId': 'OG003'}, {'value': '-10.42', 'spread': '8.815', 'groupId': 'OG004'}, {'value': '-13.70', 'spread': '10.056', 'groupId': 'OG005'}, {'value': '-13.89', 'spread': '12.288', 'groupId': 'OG006'}, {'value': '-10.22', 'spread': '12.734', 'groupId': 'OG007'}, {'value': '-14.50', 'spread': '12.031', 'groupId': 'OG008'}, {'value': '-12.78', 'spread': '14.700', 'groupId': 'OG009'}, {'value': '-14.29', 'spread': '14.136', 'groupId': 'OG010'}, {'value': '-14.84', 'spread': '13.383', 'groupId': 'OG011'}, {'value': '-17.09', 'spread': '13.194', 'groupId': 'OG012'}, {'value': '-14.52', 'spread': '15.111', 'groupId': 'OG013'}, {'value': '-17.12', 'spread': '14.016', 'groupId': 'OG014'}]}]}, {'title': 'Change in Morning DBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-6.12', 'spread': '8.457', 'groupId': 'OG000'}, {'value': '-9.20', 'spread': '10.516', 'groupId': 'OG001'}, {'value': '-7.62', 'spread': '8.033', 'groupId': 'OG002'}, {'value': '-5.01', 'spread': '7.141', 'groupId': 'OG003'}, {'value': '-6.82', 'spread': '6.279', 'groupId': 'OG004'}, {'value': '-7.53', 'spread': '8.206', 'groupId': 'OG005'}, {'value': '-9.21', 'spread': '9.474', 'groupId': 'OG006'}, {'value': '-7.86', 'spread': '8.416', 'groupId': 'OG007'}, {'value': '-10.04', 'spread': '8.489', 'groupId': 'OG008'}, {'value': '-8.79', 'spread': '10.902', 'groupId': 'OG009'}, {'value': '-11.15', 'spread': '10.411', 'groupId': 'OG010'}, {'value': '-9.96', 'spread': '10.730', 'groupId': 'OG011'}, {'value': '-11.95', 'spread': '8.060', 'groupId': 'OG012'}, {'value': '-10.71', 'spread': '11.012', 'groupId': 'OG013'}, {'value': '-12.46', 'spread': '8.763', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Morning BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'title': 'Change in Afternoon SBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-9.68', 'spread': '11.399', 'groupId': 'OG000'}, {'value': '-17.21', 'spread': '19.772', 'groupId': 'OG001'}, {'value': '-10.53', 'spread': '13.359', 'groupId': 'OG002'}, {'value': '-9.69', 'spread': '10.094', 'groupId': 'OG003'}, {'value': '-13.34', 'spread': '9.669', 'groupId': 'OG004'}, {'value': '-13.76', 'spread': '11.796', 'groupId': 'OG005'}, {'value': '-13.96', 'spread': '13.128', 'groupId': 'OG006'}, {'value': '-15.54', 'spread': '13.503', 'groupId': 'OG007'}, {'value': '-16.38', 'spread': '13.285', 'groupId': 'OG008'}, {'value': '-14.51', 'spread': '13.433', 'groupId': 'OG009'}, {'value': '-17.97', 'spread': '14.622', 'groupId': 'OG010'}, {'value': '-17.82', 'spread': '13.042', 'groupId': 'OG011'}, {'value': '-20.91', 'spread': '13.704', 'groupId': 'OG012'}, {'value': '-20.46', 'spread': '17.611', 'groupId': 'OG013'}, {'value': '-19.36', 'spread': '14.893', 'groupId': 'OG014'}]}]}, {'title': 'Change in Afternoon DBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-5.62', 'spread': '7.969', 'groupId': 'OG000'}, {'value': '-10.25', 'spread': '12.250', 'groupId': 'OG001'}, {'value': '-6.67', 'spread': '7.800', 'groupId': 'OG002'}, {'value': '-6.27', 'spread': '8.910', 'groupId': 'OG003'}, {'value': '-10.12', 'spread': '6.555', 'groupId': 'OG004'}, {'value': '-8.38', 'spread': '7.787', 'groupId': 'OG005'}, {'value': '-11.28', 'spread': '8.998', 'groupId': 'OG006'}, {'value': '-12.04', 'spread': '8.132', 'groupId': 'OG007'}, {'value': '-11.59', 'spread': '10.112', 'groupId': 'OG008'}, {'value': '-12.18', 'spread': '9.905', 'groupId': 'OG009'}, {'value': '-14.03', 'spread': '9.425', 'groupId': 'OG010'}, {'value': '-12.54', 'spread': '8.893', 'groupId': 'OG011'}, {'value': '-15.12', 'spread': '8.437', 'groupId': 'OG012'}, {'value': '-13.87', 'spread': '12.997', 'groupId': 'OG013'}, {'value': '-15.02', 'spread': '9.197', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Afternoon BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '33', 'groupId': 'OG013'}, {'value': '34', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'title': 'Change in Night SBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-9.01', 'spread': '10.635', 'groupId': 'OG000'}, {'value': '-11.58', 'spread': '16.103', 'groupId': 'OG001'}, {'value': '-10.38', 'spread': '8.600', 'groupId': 'OG002'}, {'value': '-4.28', 'spread': '8.018', 'groupId': 'OG003'}, {'value': '-7.70', 'spread': '10.178', 'groupId': 'OG004'}, {'value': '-7.71', 'spread': '9.627', 'groupId': 'OG005'}, {'value': '-10.37', 'spread': '11.517', 'groupId': 'OG006'}, {'value': '-9.94', 'spread': '11.220', 'groupId': 'OG007'}, {'value': '-12.64', 'spread': '11.301', 'groupId': 'OG008'}, {'value': '-10.02', 'spread': '10.256', 'groupId': 'OG009'}, {'value': '-11.87', 'spread': '12.031', 'groupId': 'OG010'}, {'value': '-11.25', 'spread': '11.462', 'groupId': 'OG011'}, {'value': '-12.08', 'spread': '9.486', 'groupId': 'OG012'}, {'value': '-14.12', 'spread': '12.151', 'groupId': 'OG013'}, {'value': '-13.06', 'spread': '10.651', 'groupId': 'OG014'}]}]}, {'title': 'Change in Night DBP from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-5.83', 'spread': '6.602', 'groupId': 'OG000'}, {'value': '-6.78', 'spread': '8.251', 'groupId': 'OG001'}, {'value': '-7.49', 'spread': '6.085', 'groupId': 'OG002'}, {'value': '-3.20', 'spread': '5.340', 'groupId': 'OG003'}, {'value': '-6.49', 'spread': '5.723', 'groupId': 'OG004'}, {'value': '-5.34', 'spread': '7.187', 'groupId': 'OG005'}, {'value': '-8.11', 'spread': '7.260', 'groupId': 'OG006'}, {'value': '-7.03', 'spread': '6.853', 'groupId': 'OG007'}, {'value': '-9.36', 'spread': '7.068', 'groupId': 'OG008'}, {'value': '-8.23', 'spread': '7.458', 'groupId': 'OG009'}, {'value': '-9.34', 'spread': '8.960', 'groupId': 'OG010'}, {'value': '-9.09', 'spread': '7.321', 'groupId': 'OG011'}, {'value': '-8.27', 'spread': '6.002', 'groupId': 'OG012'}, {'value': '-9.88', 'spread': '8.161', 'groupId': 'OG013'}, {'value': '-10.14', 'spread': '7.468', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Night BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': ': ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}, {'value': '42', 'groupId': 'OG009'}, {'value': '43', 'groupId': 'OG010'}, {'value': '40', 'groupId': 'OG011'}, {'value': '39', 'groupId': 'OG012'}, {'value': '43', 'groupId': 'OG013'}, {'value': '41', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 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'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'title': 'Change in sSBP by Cuff from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-11.97', 'spread': '13.671', 'groupId': 'OG000'}, {'value': '-10.85', 'spread': '12.975', 'groupId': 'OG001'}, {'value': '-13.09', 'spread': '10.200', 'groupId': 'OG002'}, {'value': '-5.68', 'spread': '10.074', 'groupId': 'OG003'}, {'value': '-5.07', 'spread': '15.610', 'groupId': 'OG004'}, {'value': '-8.88', 'spread': '15.179', 'groupId': 'OG005'}, {'value': '-9.54', 'spread': '14.373', 'groupId': 'OG006'}, {'value': '-11.84', 'spread': '16.943', 'groupId': 'OG007'}, {'value': '-13.43', 'spread': '15.279', 'groupId': 'OG008'}, {'value': '-9.79', 'spread': '14.481', 'groupId': 'OG009'}, {'value': '-11.26', 'spread': '15.056', 'groupId': 'OG010'}, {'value': '-13.49', 'spread': '17.626', 'groupId': 'OG011'}, {'value': '-6.42', 'spread': '16.409', 'groupId': 'OG012'}, {'value': '-9.00', 'spread': '14.541', 'groupId': 'OG013'}, {'value': '-14.58', 'spread': '16.176', 'groupId': 'OG014'}]}]}, {'title': 'Change in sDBP by Cuff from Baseline to Week 6', 'categories': [{'measurements': [{'value': '-7.45', 'spread': '13.671', 'groupId': 'OG000'}, {'value': '-5.32', 'spread': '8.969', 'groupId': 'OG001'}, {'value': '-10.35', 'spread': '7.627', 'groupId': 'OG002'}, {'value': '-6.87', 'spread': '5.671', 'groupId': 'OG003'}, {'value': '-5.70', 'spread': '9.760', 'groupId': 'OG004'}, {'value': '-7.54', 'spread': '8.469', 'groupId': 'OG005'}, {'value': '-5.66', 'spread': '8.949', 'groupId': 'OG006'}, {'value': '-10.02', 'spread': '10.384', 'groupId': 'OG007'}, {'value': '-10.28', 'spread': '8.543', 'groupId': 'OG008'}, {'value': '-8.73', 'spread': '10.771', 'groupId': 'OG009'}, {'value': '-10.89', 'spread': '10.757', 'groupId': 'OG010'}, {'value': '-9.63', 'spread': '11.073', 'groupId': 'OG011'}, {'value': '-8.22', 'spread': '9.203', 'groupId': 'OG012'}, {'value': '-9.45', 'spread': '11.204', 'groupId': 'OG013'}, {'value': '-10.95', 'spread': '8.624', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.'}, {'type': 'SECONDARY', 'title': 'Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '42', 'groupId': 'OG007'}, {'value': '43', 'groupId': 'OG008'}, {'value': '42', 'groupId': 'OG009'}, {'value': '43', 'groupId': 'OG010'}, {'value': '40', 'groupId': 'OG011'}, {'value': '39', 'groupId': 'OG012'}, {'value': '43', 'groupId': 'OG013'}, {'value': '41', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'OG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'OG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'OG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'OG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'OG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'OG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'OG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'OG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'OG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'OG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'OG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'OG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'OG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'OG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '27', 'groupId': 'OG011'}, {'value': '28', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '28', 'groupId': 'OG014'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'FG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'FG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'FG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'FG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'FG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'FG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'FG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'FG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'FG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'FG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'FG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'FG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'FG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'FG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '44'}, {'groupId': 'FG005', 'numSubjects': '44'}, {'groupId': 'FG006', 'numSubjects': '44'}, {'groupId': 'FG007', 'numSubjects': '43'}, {'groupId': 'FG008', 'numSubjects': '44'}, {'groupId': 'FG009', 'numSubjects': '44'}, {'groupId': 'FG010', 'numSubjects': '44'}, {'groupId': 'FG011', 'numSubjects': '43'}, {'groupId': 'FG012', 'numSubjects': '44'}, {'groupId': 'FG013', 'numSubjects': '44'}, {'groupId': 'FG014', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '36'}, {'groupId': 'FG006', 'numSubjects': '37'}, {'groupId': 'FG007', 'numSubjects': '40'}, {'groupId': 'FG008', 'numSubjects': '38'}, {'groupId': 'FG009', 'numSubjects': '35'}, {'groupId': 'FG010', 'numSubjects': '39'}, {'groupId': 'FG011', 'numSubjects': '37'}, {'groupId': 'FG012', 'numSubjects': '34'}, {'groupId': 'FG013', 'numSubjects': '36'}, {'groupId': 'FG014', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '10'}, {'groupId': 'FG013', 'numSubjects': '8'}, {'groupId': 'FG014', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Reason not listed/blank', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Per sponsors instruction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'P.I. recommended due to blood pressure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Subject did not meet end of study ABPM', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Abnormal lab values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'PI recommended early withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Did not meet criteria before ABPM', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Failed inclusion criteria #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Prolonged duration between visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Subject left town, ran out of study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Subject refuse to sign updated consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Visits conflicted with new job', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}, {'value': '44', 'groupId': 'BG008'}, {'value': '44', 'groupId': 'BG009'}, {'value': '44', 'groupId': 'BG010'}, {'value': '43', 'groupId': 'BG011'}, {'value': '44', 'groupId': 'BG012'}, {'value': '44', 'groupId': 'BG013'}, {'value': '43', 'groupId': 'BG014'}, {'value': '654', 'groupId': 'BG015'}]}], 'groups': [{'id': 'BG000', 'title': 'Lisinopril 10', 'description': 'lisinopril 10 milligrams (mg) once daily'}, {'id': 'BG001', 'title': 'Lisinopril 20', 'description': 'lisinopril 20 mg once daily'}, {'id': 'BG002', 'title': 'Lisinopril 40', 'description': 'lisinopril 40 mg once daily'}, {'id': 'BG003', 'title': 'Carvedilol Controlled Release 20', 'description': 'carvedilol controlled release (CR) 20 mg once daily'}, {'id': 'BG004', 'title': 'Carvedilol Controlled Release 40', 'description': 'carvedilol CR 40 mg once daily'}, {'id': 'BG005', 'title': 'Carvedilol Controlled Release 80', 'description': 'carvedilol CR 80 mg once daily'}, {'id': 'BG006', 'title': 'Carvedilol Controlled Release 20 Lisinopril 10', 'description': 'carvedilol CR 20 mg plus lisinopril 10 mg once daily'}, {'id': 'BG007', 'title': 'Carvedilol Controlled Release 20 Lisinopril 20', 'description': 'carvedilol CR 20 mg plus lisinopril 20 mg once daily'}, {'id': 'BG008', 'title': 'Carvedilol Controlled Release 20 Lisinopril 40', 'description': 'carvedilol CR 20 mg plus lisinopril 40 mg once daily'}, {'id': 'BG009', 'title': 'Carvedilol Controlled Release 40 Lisinopril 10', 'description': 'carvedilol CR 40 mg plus lisinopril 10 mg once daily'}, {'id': 'BG010', 'title': 'Carvedilol Controlled Release 40 Lisinopril 20', 'description': 'carvedilol CR 40 mg plus lisinopril 20 mg once daily'}, {'id': 'BG011', 'title': 'Carvedilol Controlled Release 40 Lisinopril 40', 'description': 'carvedilol CR 40 mg plus lisinopril 40 mg once daily'}, {'id': 'BG012', 'title': 'Carvedilol Controlled Release 80 Lisinopril 10', 'description': 'carvedilol CR 80 mg plus lisinopril 10 mg once daily'}, {'id': 'BG013', 'title': 'Carvedilol Controlled Release 80 Lisinopril 20', 'description': 'carvedilol CR 80 mg plus lisinopril 20 mg once daily'}, {'id': 'BG014', 'title': 'Carvedilol Controlled Release 80 Lisinopril 40', 'description': 'carvedilol CR 80 mg plus lisinopril 40 mg once daily'}, {'id': 'BG015', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '10.53', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '10.69', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '10.70', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '9.41', 'groupId': 'BG003'}, {'value': '54.1', 'spread': '10.94', 'groupId': 'BG004'}, {'value': '54.3', 'spread': '8.64', 'groupId': 'BG005'}, {'value': '53.3', 'spread': '9.60', 'groupId': 'BG006'}, {'value': '55.5', 'spread': '8.39', 'groupId': 'BG007'}, {'value': '53.5', 'spread': '10.51', 'groupId': 'BG008'}, {'value': '51.9', 'spread': '9.08', 'groupId': 'BG009'}, {'value': '51.5', 'spread': '9.32', 'groupId': 'BG010'}, {'value': '57.9', 'spread': '9.27', 'groupId': 'BG011'}, {'value': '52.5', 'spread': '11.11', 'groupId': 'BG012'}, {'value': '50.9', 'spread': '9.51', 'groupId': 'BG013'}, {'value': '51.5', 'spread': '8.69', 'groupId': 'BG014'}, {'value': '53.1', 'spread': '9.86', 'groupId': 'BG015'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '13', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '14', 'groupId': 'BG013'}, {'value': '14', 'groupId': 'BG014'}, {'value': '232', 'groupId': 'BG015'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}, {'value': '31', 'groupId': 'BG009'}, {'value': '31', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '29', 'groupId': 'BG012'}, {'value': '30', 'groupId': 'BG013'}, {'value': '29', 'groupId': 'BG014'}, {'value': '422', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}, {'value': '16', 'groupId': 'BG012'}, {'value': '14', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}, {'value': '194', 'groupId': 'BG015'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '33', 'groupId': 'BG015'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '29', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '27', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '26', 'groupId': 'BG013'}, {'value': '27', 'groupId': 'BG014'}, {'value': '417', 'groupId': 'BG015'}]}]}, {'title': 'Race not provided by patient', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2006-06-29', 'resultsFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2006-06-29', 'lastUpdatePostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-28', 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure', 'timeFrame': 'Baseline, Week 6.', 'description': 'Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).'}, {'measure': 'Change From Baseline to Week 6 in Trough Diastolic Blood Pressure', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough ABPM was the average across 20-24 hr after dosing for each subject.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure', 'timeFrame': 'Baseline, Week 6', 'description': 'Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).'}, {'measure': 'Change From Baseline to Week 6 in Trough Systolic Blood Pressure', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough ABPM was the average across 20-24 hr after dosing for each subject.'}, {'measure': 'Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)', 'timeFrame': 'Baseline, Week 6', 'description': 'Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.'}, {'measure': 'Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)', 'timeFrame': 'Baseline, Week 6', 'description': 'Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak \\> 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.'}, {'measure': 'Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.', 'timeFrame': 'Weeks 1 through 48', 'description': 'Refer to Adverse Event section for safety information.'}, {'measure': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM', 'timeFrame': 'Morning BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.'}, {'measure': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM', 'timeFrame': 'Afternoon BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.'}, {'measure': 'Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM', 'timeFrame': 'Night BP, Baseline, Week 6', 'description': 'Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.'}, {'measure': 'Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment', 'timeFrame': 'Baseline, Week 6', 'description': 'Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration'}, {'measure': 'Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)', 'timeFrame': 'Week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carvedilol', 'hypertension', 'lisinopril', 'factorial'], 'conditions': ['Hypertension']}, 'referencesModule': {'availIpds': [{'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'CFD105453', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '20883227', 'type': 'DERIVED', 'citation': 'Bakris GL, Iyengar M, Lukas MA, Ordronneau P, Weber MA. Effect of combining extended-release carvedilol and lisinopril in hypertension: results of the COSMOS study. J Clin Hypertens (Greenwich). 2010 Sep;12(9):678-86. doi: 10.1111/j.1751-7176.2010.00341.x. Epub 2010 Jul 8.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or 40 mg daily) alone, and all combinations of the doses.', 'detailedDescription': 'A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (ZESTRIL) or a Combination of One of the Doses of Each Medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has given signed informed consent.\n* Subject is male or female 18 years of age at the time informed consent is signed.\n* At the Screening visit, subject has a documented history or current presentation with stage 1 or stage 2 hypertension (see Section 15.1, Appendix 1 and Section 15.4, Appendix 4) which meets one of the following criteria. Note: All blood pressures are mean sitting cuff pressures:\n\nDocumented history of hypertension and receiving two antihypertensive medications with mean sDBP \\<90 mmHg or for diabetic subjects (defined as having an established diagnosis of diabetes or receiving treatment for diabetes), mean sDBP \\<80 mmHg. Subjects taking beta blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must be tapered off the medication during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications \\[e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications\\].) OR Receiving one antihypertensive medication with mean sDBP =109 mmHg and can be safely withdrawn from all antihypertensive medication during the Washout/Placebo Run-in phase. Any subject who is receiving beta-blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must have the dose tapered down during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase.\n\n(NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications \\[e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications\\].\n\nOR Untreated/newly diagnosed subjects: mean sDBP =95 and =109, or for diabetic subjects, mean sDBP =85 and =109 (see Section 15.1, Appendix 1). If newly diagnosed, must have qualifying blood pressure confirmed on two consecutive visits with the mean sDBP value not differing more than 8 mmHg. (Previously untreated subjects include subjects who have not been treated for hypertension in the last two months.).\n\n* At Baseline:\n\nDAY BEFORE RANDOMIZATION: Prior to having the baseline ABPM equipment placed, subject has mean sitting cuff DBP that is ≥93 and ≤111 mmHg (or for diabetic subjects, ≥83 and ≤111 mmHg). Subjects who were taking antihypertensive medication at Screening and do not meet this criterion after one week (or 5 half-lives, whichever is longer), can return in one week ±1day and have his/her blood pressure evaluated again for this inclusion criterion.\n\nAND\n\nRANDOMIZATON DAY: After completion of the ABPM assessment, subject meets the following ABPM (both 12 hr and 24 hr) criteria (see Section 15.1, Appendix 1):\n\n* Mean 12-hour daytime (9 AM to 9 PM) DBP ≥90 and ≤109mmHg (or for diabetic subjects, ≥80 and ≤109mmHg)\n* At least 75% of the programmed readings properly recorded over 24-hour monitoring period\n* No more than two non-consecutive hours with less than two successful readings per hour while awake, and no more than two consecutive hours with less than one successful reading per hour during the sleep period over the 24-hour monitoring period\n* At least two successful readings per hour for three of the last four hours of recording (trough period i.e., 20-24 hour during which subjects must be awake) with a total of at least 7 successful readings over this period.\n\nExclusion Criteria:\n\n* Subject is taking ≥3 antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications \\[e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications\\].)\n* Subject has DBP =90 mmHg (or for diabetic subjects, DBP =80 mmHg) on two antihypertensive medications.\n* Subject has any known contraindication to ACE inhibitors (e.g., ACE-induced cough, angioedema or negative renal effects), or blocker treatment.\n* Hyperkalemia or history of hyperkalemia resulting from either Type IV RTA (renal tubular acidosis) or previous ACEi therapy.\n* Is female of childbearing potential. NOTE: Female subjects who are postmenopausal (i.e., no menstrual period for a minimum of 12 months prior to Screening) or surgically sterilized are eligible for the study. If judged appropriate, a postmenopausal woman may be required to have a documented negative urine pregnancy test.\n* Subject has malignant (accelerated) hypertension, history of malignant hypertension, or secondary forms of hypertension.\n* Subject has mean sitting SBP =180 mmHg.\n* Subject has advanced hypertensive retinopathy (Keith Wagner Grade IV).\n* Subject has Type 1 diabetes mellitus, or those with Type 2 having HbA1c ≥9% at Screening.\n* Subject has uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies.\n* Subject has any of the following conditions:\n\nuncontrollable or symptomatic arrhythmias unstable angina or angina treated with a beta-blocker sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker) bradycardia (sitting heart rate \\<55 bpm) history of myocardial infarction stroke within 3 months of Screening\n\n* Subject is in atrial fibrillation.\n* Subject has Congestive Heart Failure NYHA (New York Heart Association) class II-IV \\[The Criteria Committee of the New York Heart Association, 1994\\].\n* Current clinical evidence of asthma or chronic obstructive pulmonary disease (e.g., severe emphysema or chronic bronchitis) requiring long term use of inhaled oral bronchodilator or steroid drug therapy; also subjects with a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with the study medication could provoke bronchospasm; or requirement for or anticipated treatment with beta-2 agonist therapy (e.g., albuterol \\[Ventolin, Proventil\\], metaproterenol \\[Alupent\\], pirbuterol \\[Maxair\\], terbutaline \\[Brethaire\\], isoetharine \\[Bronkosol\\], and Levalbuterol \\[Xopenex\\]).\n* Subject has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication:\n\nrenal disease defined as estimated Glomerular Filtration Rate (eGFR) \\<30mL/min per 1.73 m2 hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment) chronic biliary disorders gastric bypass surgery\n\n* Subject has endocrine disorders that affect blood pressure (e.g., pheochromocytoma, active and untreated hypo- or hyperthyroidism).\n* Subject has systemic disease, including cancer, with reduced (\\<12 months) life expectancy.\n* Subject has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Screening.\n* Subject has a history of a psychological illness/condition that would interfere with their ability to understand or complete the requirements of the study.\n* Subject has any condition that, in the opinion of the Investigator and/or the GSK Medical Monitor, places the subject at an unacceptable risk as a participant in this trial.\n* Subject is receiving ongoing treatment or is anticipated to receive treatment with any of the following medications during treatment with double blind study medication:\n\nany antihypertensive medication except for assigned study medication. This would include alpha blockers or other medications that may be used to treat hypertension and other conditions unrelated to hypertension; monoamine oxidase (MAO) inhibitors; any Class I or III antiarrhythmic; beta-2-agonists."}, 'identificationModule': {'nctId': 'NCT00347360', 'briefTitle': 'The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment With 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (Zestril) or a Combination of One of the Doses of Each Medication', 'orgStudyIdInfo': {'id': 'CFD105453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lisinopril', 'description': 'lisinopril', 'interventionNames': ['Drug: lisinopril']}, {'type': 'EXPERIMENTAL', 'label': 'carvedilol', 'description': 'carvedilol controlled release formulation', 'interventionNames': ['Drug: carvedilol controlled release formulation']}], 'interventions': [{'name': 'lisinopril', 'type': 'DRUG', 'armGroupLabels': ['lisinopril']}, {'name': 'carvedilol controlled release formulation', 'type': 'DRUG', 'otherNames': ['lisinopril'], 'armGroupLabels': ['carvedilol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': 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