Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-28 @ 2:06 PM
Study NCT ID:
NCT01096667
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2010-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Malaysia', 'Puerto Rico', 'Serbia', 'Taiwan', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570288', 'term': 'ertugliflozin'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure (poster presentation, invited speaker or guest lecturer presentation, etc.) to the sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, Investigator agrees to delay the disclosure for a period not to exceed an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 63 days (including screening and run-in [pre-randomization], treatment period, and follow-up)', 'description': 'Serious adverse events include all randomized participants who received at least one dose of study drug except for the pre-randomization arm that includes all randomized participants. Non-serious adverse events include all randomized participants who received at least one dose of study drug (all arms).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.', 'otherNumAtRisk': 38, 'otherNumAffected': 3, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days', 'otherNumAtRisk': 39, 'otherNumAffected': 4, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days', 'otherNumAtRisk': 38, 'otherNumAffected': 8, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days', 'otherNumAtRisk': 39, 'otherNumAffected': 6, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days', 'otherNumAtRisk': 39, 'otherNumAffected': 6, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Pre-randomization', 'description': 'Blinded placebo was administered for at least 21 days prior to randomization.', 'otherNumAtRisk': 193, 'otherNumAffected': 10, 'seriousNumAtRisk': 194, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Genital infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Athralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 193, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline 24-hour Average Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '136.11', 'spread': '15.298', 'groupId': 'OG000'}, {'value': '133.13', 'spread': '10.868', 'groupId': 'OG001'}, {'value': '135.08', 'spread': '12.073', 'groupId': 'OG002'}, {'value': '135.59', 'spread': '11.929', 'groupId': 'OG003'}, {'value': '139.55', 'spread': '11.941', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour SBP.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline on 24-hour Average SBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '-1.31', 'upperLimit': '1.70'}, {'value': '-2.71', 'groupId': 'OG001', 'lowerLimit': '-4.15', 'upperLimit': '-1.33'}, {'value': '-3.73', 'groupId': 'OG002', 'lowerLimit': '-5.30', 'upperLimit': '-2.18'}, {'value': '-3.42', 'groupId': 'OG003', 'lowerLimit': '-4.86', 'upperLimit': '-1.99'}, {'value': '-2.95', 'groupId': 'OG004', 'lowerLimit': '-4.39', 'upperLimit': '-1.51'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.97', 'ciLowerLimit': '-5.05', 'ciUpperLimit': '-0.89', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.00', 'ciLowerLimit': '-6.17', 'ciUpperLimit': '-1.82', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.69', 'ciLowerLimit': '-5.78', 'ciUpperLimit': '-1.60', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.21', 'ciLowerLimit': '-5.30', 'ciUpperLimit': '-1.13', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Baseline Average Daytime and Nighttime SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'title': 'Daytime', 'categories': [{'measurements': [{'value': '139.95', 'spread': '15.107', 'groupId': 'OG000'}, {'value': '136.85', 'spread': '11.361', 'groupId': 'OG001'}, {'value': '138.89', 'spread': '11.724', 'groupId': 'OG002'}, {'value': '139.56', 'spread': '12.343', 'groupId': 'OG003'}, {'value': '143.32', 'spread': '12.637', 'groupId': 'OG004'}]}]}, {'title': 'Nighttime', 'categories': [{'measurements': [{'value': '127.54', 'spread': '16.858', 'groupId': 'OG000'}, {'value': '125.15', 'spread': '12.180', 'groupId': 'OG001'}, {'value': '126.37', 'spread': '13.956', 'groupId': 'OG002'}, {'value': '127.13', 'spread': '13.553', 'groupId': 'OG003'}, {'value': '131.68', 'spread': '12.912', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daytime: 16 hours; Nighttime: 8 hours', 'description': 'Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for daytime and nighttime SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Daytime Average SBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '2.34'}, {'value': '-2.88', 'groupId': 'OG001', 'lowerLimit': '-4.49', 'upperLimit': '-1.44'}, {'value': '-3.61', 'groupId': 'OG002', 'lowerLimit': '-5.30', 'upperLimit': '-1.94'}, {'value': '-4.17', 'groupId': 'OG003', 'lowerLimit': '-5.72', 'upperLimit': '-2.63'}, {'value': '-3.10', 'groupId': 'OG004', 'lowerLimit': '-4.66', 'upperLimit': '-1.57'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.70', 'ciLowerLimit': '-5.94', 'ciUpperLimit': '-1.46', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.43', 'ciLowerLimit': '-6.78', 'ciUpperLimit': '-2.09', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.99', 'ciLowerLimit': '-7.24', 'ciUpperLimit': '-2.74', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.92', 'ciLowerLimit': '-6.16', 'ciUpperLimit': '-1.67', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Nighttime Average SBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG000', 'lowerLimit': '-2.28', 'upperLimit': '1.71'}, {'value': '-2.48', 'groupId': 'OG001', 'lowerLimit': '-4.33', 'upperLimit': '-0.60'}, {'value': '-3.47', 'groupId': 'OG002', 'lowerLimit': '-5.53', 'upperLimit': '-1.39'}, {'value': '-2.31', 'groupId': 'OG003', 'lowerLimit': '-4.21', 'upperLimit': '-0.40'}, {'value': '-2.30', 'groupId': 'OG004', 'lowerLimit': '-4.20', 'upperLimit': '-0.40'}]}]}], 'analyses': [{'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.19', 'ciLowerLimit': '-4.93', 'ciUpperLimit': '0.54', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.078', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.18', 'ciLowerLimit': '-6.06', 'ciUpperLimit': '-0.30', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.02', 'ciLowerLimit': '-4.79', 'ciUpperLimit': '0.74', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.01', 'ciLowerLimit': '-4.77', 'ciUpperLimit': '0.74', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Baseline Seated, Triplicate Trough SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '135.17', 'spread': '14.183', 'groupId': 'OG000'}, {'value': '134.23', 'spread': '13.631', 'groupId': 'OG001'}, {'value': '137.31', 'spread': '14.834', 'groupId': 'OG002'}, {'value': '135.25', 'spread': '13.452', 'groupId': 'OG003'}, {'value': '138.07', 'spread': '12.958', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seated, Triplicate Trough SBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '3.41'}, {'value': '-2.77', 'groupId': 'OG001', 'lowerLimit': '-4.95', 'upperLimit': '-0.60'}, {'value': '-5.92', 'groupId': 'OG002', 'lowerLimit': '-8.12', 'upperLimit': '-3.73'}, {'value': '-4.96', 'groupId': 'OG003', 'lowerLimit': '-7.15', 'upperLimit': '-2.77'}, {'value': '-3.13', 'groupId': 'OG004', 'lowerLimit': '-5.26', 'upperLimit': '-1.00'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.01', 'ciLowerLimit': '-7.09', 'ciUpperLimit': '-0.94', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.16', 'ciLowerLimit': '-10.25', 'ciUpperLimit': '-4.07', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.20', 'ciLowerLimit': '-9.28', 'ciUpperLimit': '-3.11', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.033', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.37', 'ciLowerLimit': '-7.41', 'ciUpperLimit': '-1.33', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough SBP.'}, {'type': 'SECONDARY', 'title': 'Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'title': '24-hr', 'categories': [{'measurements': [{'value': '81.89', 'spread': '9.655', 'groupId': 'OG000'}, {'value': '78.67', 'spread': '8.600', 'groupId': 'OG001'}, {'value': '80.18', 'spread': '8.655', 'groupId': 'OG002'}, {'value': '80.36', 'spread': '8.650', 'groupId': 'OG003'}, {'value': '82.66', 'spread': '9.459', 'groupId': 'OG004'}]}]}, {'title': 'Daytime', 'categories': [{'measurements': [{'value': '85.32', 'spread': '10.127', 'groupId': 'OG000'}, {'value': '81.77', 'spread': '8.925', 'groupId': 'OG001'}, {'value': '83.47', 'spread': '9.164', 'groupId': 'OG002'}, {'value': '83.59', 'spread': '9.295', 'groupId': 'OG003'}, {'value': '85.87', 'spread': '9.884', 'groupId': 'OG004'}]}]}, {'title': 'Nighttime', 'categories': [{'measurements': [{'value': '74.24', 'spread': '9.717', 'groupId': 'OG000'}, {'value': '72.05', 'spread': '9.330', 'groupId': 'OG001'}, {'value': '73.05', 'spread': '9.034', 'groupId': 'OG002'}, {'value': '73.28', 'spread': '8.760', 'groupId': 'OG003'}, {'value': '75.76', 'spread': '10.042', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours', 'description': 'Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime DBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on 24-hour Average DBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '1.75'}, {'value': '-1.89', 'groupId': 'OG001', 'lowerLimit': '-2.81', 'upperLimit': '-0.95'}, {'value': '-2.34', 'groupId': 'OG002', 'lowerLimit': '-3.37', 'upperLimit': '-1.31'}, {'value': '-1.50', 'groupId': 'OG003', 'lowerLimit': '-2.45', 'upperLimit': '-0.55'}, {'value': '-1.42', 'groupId': 'OG004', 'lowerLimit': '-2.37', 'upperLimit': '-0.48'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.66', 'ciLowerLimit': '-4.03', 'ciUpperLimit': '-1.29', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.11', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '-1.67', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.27', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '-0.88', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.19', 'ciLowerLimit': '-3.56', 'ciUpperLimit': '-0.82', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Daytime Average DBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '1.85'}, {'value': '-2.12', 'groupId': 'OG001', 'lowerLimit': '-3.13', 'upperLimit': '-1.18'}, {'value': '-1.88', 'groupId': 'OG002', 'lowerLimit': '-2.96', 'upperLimit': '-0.80'}, {'value': '-1.77', 'groupId': 'OG003', 'lowerLimit': '-2.77', 'upperLimit': '-0.78'}, {'value': '-1.69', 'groupId': 'OG004', 'lowerLimit': '-2.67', 'upperLimit': '-0.70'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.99', 'ciLowerLimit': '-4.43', 'ciUpperLimit': '-1.55', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.75', 'ciLowerLimit': '-4.26', 'ciUpperLimit': '-1.24', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.64', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '-1.19', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.57', 'ciLowerLimit': '-4.00', 'ciUpperLimit': '-1.13', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Nighttime Average DBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '2.44'}, {'value': '-1.48', 'groupId': 'OG001', 'lowerLimit': '-2.78', 'upperLimit': '-0.15'}, {'value': '-2.52', 'groupId': 'OG002', 'lowerLimit': '-3.98', 'upperLimit': '-1.06'}, {'value': '-0.84', 'groupId': 'OG003', 'lowerLimit': '-2.19', 'upperLimit': '0.51'}, {'value': '-0.55', 'groupId': 'OG004', 'lowerLimit': '-1.95', 'upperLimit': '0.71'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.50', 'ciLowerLimit': '-4.43', 'ciUpperLimit': '-0.57', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.54', 'ciLowerLimit': '-5.58', 'ciUpperLimit': '-1.51', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.88', 'ciLowerLimit': '-3.82', 'ciUpperLimit': '0.09', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.148', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.58', 'ciLowerLimit': '-3.51', 'ciUpperLimit': '0.36', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Baseline Seated, Triplicate Trough DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '84.89', 'spread': '9.462', 'groupId': 'OG000'}, {'value': '83.08', 'spread': '7.557', 'groupId': 'OG001'}, {'value': '83.79', 'spread': '7.904', 'groupId': 'OG002'}, {'value': '83.89', 'spread': '8.290', 'groupId': 'OG003'}, {'value': '84.72', 'spread': '8.043', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough DBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seated, Triplicate Trough DBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '-0.97', 'upperLimit': '1.58'}, {'value': '-0.90', 'groupId': 'OG001', 'lowerLimit': '-2.18', 'upperLimit': '0.37'}, {'value': '-0.75', 'groupId': 'OG002', 'lowerLimit': '-2.03', 'upperLimit': '0.54'}, {'value': '-2.71', 'groupId': 'OG003', 'lowerLimit': '-4.00', 'upperLimit': '-1.43'}, {'value': '-2.54', 'groupId': 'OG004', 'lowerLimit': '-3.79', 'upperLimit': '-1.29'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.20', 'ciLowerLimit': '-3.01', 'ciUpperLimit': '0.60', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Measures Repeated Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.229', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.05', 'ciLowerLimit': '-2.86', 'ciUpperLimit': '0.77', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Measures Repeated Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.02', 'ciLowerLimit': '-4.83', 'ciUpperLimit': '-1.20', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Measures Repeated Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.84', 'ciLowerLimit': '-4.63', 'ciUpperLimit': '-1.06', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Measures Repeated Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.', 'unitOfMeasure': 'mmHg', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough DBP.'}, {'type': 'SECONDARY', 'title': 'Baseline 24-hour, Daytime and Nightime Average Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'title': '24-hr', 'categories': [{'measurements': [{'value': '81.11', 'spread': '9.486', 'groupId': 'OG000'}, {'value': '80.74', 'spread': '6.950', 'groupId': 'OG001'}, {'value': '79.68', 'spread': '10.081', 'groupId': 'OG002'}, {'value': '79.41', 'spread': '9.063', 'groupId': 'OG003'}, {'value': '79.08', 'spread': '9.216', 'groupId': 'OG004'}]}]}, {'title': 'Daytime', 'categories': [{'measurements': [{'value': '84.43', 'spread': '9.743', 'groupId': 'OG000'}, {'value': '83.74', 'spread': '7.044', 'groupId': 'OG001'}, {'value': '82.71', 'spread': '10.405', 'groupId': 'OG002'}, {'value': '82.18', 'spread': '9.136', 'groupId': 'OG003'}, {'value': '81.95', 'spread': '9.470', 'groupId': 'OG004'}]}]}, {'title': 'Nighttime', 'categories': [{'measurements': [{'value': '74.05', 'spread': '9.871', 'groupId': 'OG000'}, {'value': '74.44', 'spread': '8.133', 'groupId': 'OG001'}, {'value': '73.16', 'spread': '10.205', 'groupId': 'OG002'}, {'value': '73.49', 'spread': '10.034', 'groupId': 'OG003'}, {'value': '73.03', 'spread': '9.736', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours', 'description': 'Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime heart rate.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on 24-hour Average Heart Rate at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '2.16'}, {'value': '-1.22', 'groupId': 'OG001', 'lowerLimit': '-2.45', 'upperLimit': '-0.25'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '-0.16', 'upperLimit': '2.29'}, {'value': '-1.39', 'groupId': 'OG003', 'lowerLimit': '-2.52', 'upperLimit': '-0.26'}, {'value': '-0.56', 'groupId': 'OG004', 'lowerLimit': '-1.68', 'upperLimit': '0.56'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.22', 'ciLowerLimit': '-3.83', 'ciUpperLimit': '-0.61', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.521', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.07', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '1.77', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.39', 'ciLowerLimit': '-4.02', 'ciUpperLimit': '-0.75', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.110', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.56', 'ciLowerLimit': '-3.19', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': '80% 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'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '2.83'}, {'value': '-1.80', 'groupId': 'OG001', 'lowerLimit': '-3.09', 'upperLimit': '-0.70'}, {'value': '1.10', 'groupId': 'OG002', 'lowerLimit': '-0.24', 'upperLimit': '2.43'}, {'value': '-1.07', 'groupId': 'OG003', 'lowerLimit': '-2.31', 'upperLimit': '0.15'}, {'value': '-0.06', 'groupId': 'OG004', 'lowerLimit': '-1.22', 'upperLimit': '1.22'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.38', 'ciLowerLimit': '-5.13', 'ciUpperLimit': '-1.63', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.370', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.48', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '1.38', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.65', 'ciLowerLimit': '-4.43', 'ciUpperLimit': '-0.87', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.118', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.64', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Nighttime Average Heart Rate at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-1.63', 'upperLimit': '1.25'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-1.76', 'upperLimit': '0.91'}, {'value': '1.43', 'groupId': 'OG002', 'lowerLimit': '-0.07', 'upperLimit': '2.92'}, {'value': '-1.99', 'groupId': 'OG003', 'lowerLimit': '-3.38', 'upperLimit': '-0.63'}, {'value': '-1.24', 'groupId': 'OG004', 'lowerLimit': '-2.70', 'upperLimit': '0.00'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.02', 'ciLowerLimit': '-1.96', 'ciUpperLimit': '2.00', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.838', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.61', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '3.71', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.123', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.82', 'ciLowerLimit': '-3.82', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.246', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.07', 'ciLowerLimit': '-3.06', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.'}, {'type': 'SECONDARY', 'title': 'Baseline Seated, Triplicate Trough Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '77.07', 'spread': '9.713', 'groupId': 'OG000'}, {'value': '78.73', 'spread': '8.446', 'groupId': 'OG001'}, {'value': '77.30', 'spread': '11.749', 'groupId': 'OG002'}, {'value': '75.63', 'spread': '9.550', 'groupId': 'OG003'}, {'value': '77.97', 'spread': '11.462', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough heart rate.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '3.82'}, {'value': '-1.86', 'groupId': 'OG001', 'lowerLimit': '-3.35', 'upperLimit': '-0.38'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '-0.28', 'upperLimit': '2.71'}, {'value': '-1.51', 'groupId': 'OG003', 'lowerLimit': '-3.01', 'upperLimit': '-0.01'}, {'value': '-0.99', 'groupId': 'OG004', 'lowerLimit': '-2.44', 'upperLimit': '0.46'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.20', 'ciLowerLimit': '-6.30', 'ciUpperLimit': '-2.10', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.248', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.12', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '0.99', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.84', 'ciLowerLimit': '-5.95', 'ciUpperLimit': '-1.73', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.33', 'ciLowerLimit': '-5.40', 'ciUpperLimit': '-1.25', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.', 'unitOfMeasure': 'beats per minute', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough heart rate.'}, {'type': 'SECONDARY', 'title': 'Baseline 24-hour Average Urinary Glucose Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '13.35', 'spread': '22.913', 'groupId': 'OG000'}, {'value': '9.97', 'spread': '20.085', 'groupId': 'OG001'}, {'value': '8.04', 'spread': '13.135', 'groupId': 'OG002'}, {'value': '17.56', 'spread': '29.101', 'groupId': 'OG003'}, {'value': '6.96', 'spread': '8.562', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \\>20 hours and \\<28 hours).', 'unitOfMeasure': 'grams/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a baseline measurement for average urinary glucose excretion'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'groupId': 'OG000', 'lowerLimit': '-3.50', 'upperLimit': '11.81'}, {'value': '46.33', 'groupId': 'OG001', 'lowerLimit': '38.79', 'upperLimit': '53.88'}, {'value': '64.54', 'groupId': 'OG002', 'lowerLimit': '56.77', 'upperLimit': '72.31'}, {'value': '74.49', 'groupId': 'OG003', 'lowerLimit': '66.87', 'upperLimit': '82.11'}, {'value': '-0.48', 'groupId': 'OG004', 'lowerLimit': '-7.76', 'upperLimit': '6.80'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '42.18', 'ciLowerLimit': '31.42', 'ciUpperLimit': '52.94', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '60.39', 'ciLowerLimit': '49.47', 'ciUpperLimit': '71.31', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '70.34', 'ciLowerLimit': '59.58', 'ciUpperLimit': '81.10', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}, {'pValue': '0.713', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.63', 'ciLowerLimit': '-15.22', 'ciUpperLimit': '5.96', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on ANCOVA with treatment as fixed effect and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \\>20 hours and \\<28 hours). In the case of missing data, LOCF.', 'unitOfMeasure': 'grams/day', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for 24-hour urinary glucose excretion.'}, {'type': 'SECONDARY', 'title': 'Baseline Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '169.47', 'spread': '51.073', 'groupId': 'OG000'}, {'value': '158.38', 'spread': '40.806', 'groupId': 'OG001'}, {'value': '158.29', 'spread': '42.465', 'groupId': 'OG002'}, {'value': '172.03', 'spread': '55.878', 'groupId': 'OG003'}, {'value': '156.87', 'spread': '36.541', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'groupId': 'OG000', 'lowerLimit': '-2.16', 'upperLimit': '10.94'}, {'value': '-13.70', 'groupId': 'OG001', 'lowerLimit': '-20.35', 'upperLimit': '-7.06'}, {'value': '-30.41', 'groupId': 'OG002', 'lowerLimit': '-37.12', 'upperLimit': '-23.71'}, {'value': '-31.03', 'groupId': 'OG003', 'lowerLimit': '-37.74', 'upperLimit': '-24.32'}, {'value': '3.79', 'groupId': 'OG004', 'lowerLimit': '-2.74', 'upperLimit': '10.31'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-18.10', 'ciLowerLimit': '-27.45', 'ciUpperLimit': '-8.75', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-34.81', 'ciLowerLimit': '-44.19', 'ciUpperLimit': '-25.43', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-35.42', 'ciLowerLimit': '-44.78', 'ciUpperLimit': '-26.07', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.467', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.61', 'ciLowerLimit': '-9.86', 'ciUpperLimit': '8.65', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 4 for FPG (observed cases).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.44', 'groupId': 'OG000', 'lowerLimit': '-11.93', 'upperLimit': '1.04'}, {'value': '-10.98', 'groupId': 'OG001', 'lowerLimit': '-17.69', 'upperLimit': '-4.26'}, {'value': '-22.45', 'groupId': 'OG002', 'lowerLimit': '-29.23', 'upperLimit': '-15.67'}, {'value': '-32.03', 'groupId': 'OG003', 'lowerLimit': '-38.66', 'upperLimit': '-25.40'}, {'value': '3.21', 'groupId': 'OG004', 'lowerLimit': '-3.32', 'upperLimit': '9.74'}]}]}], 'analyses': [{'pValue': '0.224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-5.54', 'ciLowerLimit': '-14.89', 'ciUpperLimit': '3.82', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-17.00', 'ciLowerLimit': '-26.39', 'ciUpperLimit': '-7.61', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-26.59', 'ciLowerLimit': '-35.84', 'ciUpperLimit': '-17.33', 'pValueComment': 'P-value is one-sided. P-value rounded to thousandths.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}, {'pValue': '0.886', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '8.65', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '17.87', 'pValueComment': 'P-value is one-sided.', 'statisticalMethod': 'Mixed Model for Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 2', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 2 for FPG (observed cases).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 63 days (including run-in, treatment period, and follow-up)', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'OG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'OG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days (treatment period)', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all randomized participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to hydrochlorothiazide (HCTZ), once daily for 28 days.'}, {'id': 'FG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'FG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'FG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'FG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Reason not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Prior to randomization, 194 participants received placebo for at least 3 weeks (completed the run-in period). Treated participants included all randomized participants who received at least one dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '193', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.'}, {'id': 'BG001', 'title': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'BG002', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'BG003', 'title': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days'}, {'id': 'BG004', 'title': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', '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'}]}]}, {'title': 'Between 18 and 44 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'Between 45 and 64 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '168', 'groupId': 'BG005'}]}]}, {'title': '65 years and older', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '131', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population includes participants who received at least 1 dose of blinded treatment regimen.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2013-04-10', 'completionDateStruct': {'date': '2011-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2010-03-26', 'dispFirstSubmitQcDate': '2013-04-10', 'resultsFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2010-03-30', 'dispFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-15', 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline 24-hour Average Systolic Blood Pressure (SBP)', 'timeFrame': '24 hours', 'description': 'Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).'}, {'measure': 'Change From Baseline on 24-hour Average SBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).'}], 'secondaryOutcomes': [{'measure': 'Baseline Average Daytime and Nighttime SBP', 'timeFrame': 'Daytime: 16 hours; Nighttime: 8 hours', 'description': 'Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on Daytime Average SBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on Nighttime Average SBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Baseline Seated, Triplicate Trough SBP', 'timeFrame': 'Baseline', 'description': 'Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.'}, {'measure': 'Change From Baseline in Seated, Triplicate Trough SBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.'}, {'measure': 'Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)', 'timeFrame': 'up to 24 hours', 'description': 'Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on 24-hour Average DBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.'}, {'measure': 'Change From Baseline on Daytime Average DBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on Nighttime Average DBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Baseline Seated, Triplicate Trough DBP', 'timeFrame': 'Baseline', 'description': 'Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.'}, {'measure': 'Change From Baseline in Seated, Triplicate Trough DBP at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.'}, {'measure': 'Baseline 24-hour, Daytime and Nightime Average Heart Rate', 'timeFrame': 'up to 24 hours', 'description': 'Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on 24-hour Average Heart Rate at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.'}, {'measure': 'Change From Baseline on Daytime Average Heart Rate at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.'}, {'measure': 'Change From Baseline on Nighttime Average Heart Rate at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.'}, {'measure': 'Baseline Seated, Triplicate Trough Heart Rate', 'timeFrame': 'Baseline', 'description': 'Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.'}, {'measure': 'Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.'}, {'measure': 'Baseline 24-hour Average Urinary Glucose Excretion', 'timeFrame': '24 hours', 'description': 'Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \\>20 hours and \\<28 hours).'}, {'measure': 'Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \\>20 hours and \\<28 hours). In the case of missing data, LOCF.'}, {'measure': 'Baseline Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).'}, {'measure': 'Change From Baseline in FPG at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).'}, {'measure': 'Change From Baseline in FPG at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to 63 days (including run-in, treatment period, and follow-up)', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to 28 days (treatment period)', 'description': 'An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'hypertension', 'ambulatory blood pressure monitoring'], 'conditions': ['Diabetes Mellitus, Type 2', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '25951755', 'type': 'RESULT', 'citation': 'Amin NB, Wang X, Mitchell JR, Lee DS, Nucci G, Rusnak JM. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015 Aug;17(8):805-8. doi: 10.1111/dom.12486. Epub 2015 Jun 17.'}, {'pmid': '34213819', 'type': 'DERIVED', 'citation': 'Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin \\[1, 5, or 25 mg\\], or the approved drug hydrochlorothiazide \\[HCTZ\\]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with type 2 diabetes and hypertension\n* Medically stable\n* On at least 1 (and up to 2) oral diabetes drugs\n* And up to 2 medicines for blood pressure control\n\nExclusion Criteria:\n\n* Participants with type 1 diabetes\n* Heart attack\n* Stroke\n* Uncontrolled blood pressure\n* Significant kidney disease'}, 'identificationModule': {'nctId': 'NCT01096667', 'briefTitle': 'Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control', 'orgStudyIdInfo': {'id': '8835-042'}, 'secondaryIdInfos': [{'id': 'B1521004', 'type': 'OTHER', 'domain': 'Pfizer protocol number'}, {'id': 'MK-8835-042', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.', 'interventionNames': ['Drug: Placebo to Ertuglilflozin 1 or 5 mg', 'Drug: Placebo to HCTZ', 'Drug: Placebo to ertuglilflozin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 1 mg', 'description': 'Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days', 'interventionNames': ['Drug: Ertugliflozin 1 mg', 'Drug: Placebo to HCTZ', 'Drug: Placebo to ertuglilflozin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days', 'interventionNames': ['Drug: Ertugliflozin 5 mg', 'Drug: Placebo to HCTZ', 'Drug: Placebo to ertuglilflozin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 25 mg', 'description': 'Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days', 'interventionNames': ['Drug: Placebo to Ertuglilflozin 1 or 5 mg', 'Drug: Ertugliflozin 25 mg', 'Drug: Placebo to HCTZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HCTZ 12.5mg', 'description': 'HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days', 'interventionNames': ['Drug: Placebo to Ertuglilflozin 1 or 5 mg', 'Drug: HCTZ 12.5mg', 'Drug: Placebo to ertuglilflozin 25 mg']}], 'interventions': [{'name': 'Placebo to Ertuglilflozin 1 or 5 mg', 'type': 'DRUG', 'description': 'Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 25 mg', 'HCTZ 12.5mg', 'Placebo']}, {'name': 'Ertugliflozin 1 mg', 'type': 'DRUG', 'description': 'Ertugliflozin tablet 1 mg once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 1 mg']}, {'name': 'Ertugliflozin 5 mg', 'type': 'DRUG', 'description': 'Ertugliflozin tablet 5 mg once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 5 mg']}, {'name': 'Ertugliflozin 25 mg', 'type': 'DRUG', 'description': 'Ertugliflozin tablet 25 mg once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 25 mg']}, {'name': 'HCTZ 12.5mg', 'type': 'DRUG', 'description': 'Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days', 'armGroupLabels': ['HCTZ 12.5mg']}, {'name': 'Placebo to HCTZ', 'type': 'DRUG', 'description': 'Placebo to HCTZ 12.5 mg capsule once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 1 mg', 'Ertugliflozin 25 mg', 'Ertugliflozin 5 mg', 'Placebo']}, {'name': 'Placebo to ertuglilflozin 25 mg', 'type': 'DRUG', 'description': 'Placebo to ertuglilflozin tablet 25 mg once daily for 28 days', 'armGroupLabels': ['Ertugliflozin 1 mg', 'Ertugliflozin 5 mg', 'HCTZ 12.5mg', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}