Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 5:45 PM
Study NCT ID:
NCT01307033
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2011-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505809', 'term': 'hydrochlorothiazide, losartan drug combination'}]}}, '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': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'All-Patients-as-Treated (APaT) Population defined as all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-0954H (L50/H12.5) Double Blind Period (Period 1)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)', 'otherNumAtRisk': 144, 'otherNumAffected': 18, 'seriousNumAtRisk': 144, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MK-0954A (L100/H12.5) Double Blind Period (Period 1)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)', 'otherNumAtRisk': 134, 'otherNumAffected': 20, 'seriousNumAtRisk': 134, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'L50/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)', 'otherNumAtRisk': 131, 'otherNumAffected': 47, 'seriousNumAtRisk': 131, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'L100/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension', 'otherNumAtRisk': 127, 'otherNumAffected': 43, 'seriousNumAtRisk': 127, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 36, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 34, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0954H (L50/H12.5)', 'description': 'One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).'}, {'id': 'OG001', 'title': 'MK-0954A (L100/H12.5)', 'description': 'One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '-3.9'}, {'value': '-5.0', 'spread': '0.7', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '-3.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.2', 'statisticalMethod': 'Constained logitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8 (End of Double-blind Period)', 'description': 'Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0954H (L50/H12.5)', 'description': 'One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)'}, {'id': 'OG001', 'title': 'MK-0954A (L100/H12.5)', 'description': 'One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'groupId': 'OG000', 'lowerLimit': '-8.2', 'upperLimit': '-4.3'}, {'value': '-8.5', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '-6.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Constained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8 (End of Double-blind Period)', 'description': 'Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'L50/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)'}, {'id': 'OG001', 'title': 'L100/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension'}], 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-0954H (L50/H12.5) Double Blind Period (Period 1)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)'}, {'id': 'FG001', 'title': 'MK-0954A (L100/H12.5) Double Blind Period (Period 1)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)'}, {'id': 'FG002', 'title': 'L50/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)'}, {'id': 'FG003', 'title': 'L100/H12.5→L100/H12.5 Open Label (Period 2)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension'}], 'periods': [{'title': '8-week Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Blood Pressure Withdrawal Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Potassium Withdrawal Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '44-week Open-label Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '131'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Blood Pressure Withdrawal Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Potassium Withdrawal Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-0954H (L50/H12.5)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)'}, {'id': 'BG001', 'title': 'MK-0954A (L100/H12.5)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2012-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2011-03-01', 'resultsFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2011-03-01', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-14', 'studyFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)', 'timeFrame': 'Up to 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8', 'timeFrame': 'Baseline and Week 8 (End of Double-blind Period)', 'description': 'Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.'}, {'measure': 'Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8', 'timeFrame': 'Baseline and Week 8 (End of Double-blind Period)', 'description': 'Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential hypertension', 'Uncontrolled hypertension', 'Antihypertensive agents', 'Blood pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24990091', 'type': 'RESULT', 'citation': 'Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Participant has a diagnosis of essential hypertension.\n* Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.\n* Participant has a mean trough SiDBP of \\>=90mmHg and \\< 110mmHg.\n* Participant has a mean trough SiSBP of \\>=140mmHg and \\< 200mmHg.\n* Participant has no clinically significant abnormality at screening visit.\n\nExclusion criteria:\n\n* Participant is currently taking \\> 2 antihypertensive medications.\n* Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).\n* Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.\n* Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.\n* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.'}, 'identificationModule': {'nctId': 'NCT01307033', 'briefTitle': 'A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase III, Randomized, Active-comparator Controlled and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]', 'orgStudyIdInfo': {'id': '0954A-351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MK-954H (L50/H12.5)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)', 'interventionNames': ['Drug: MK-954H', 'Drug: Placebo to MK-0954A']}, {'type': 'EXPERIMENTAL', 'label': 'MK-0954A (L100/H12.5)', 'description': 'One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension', 'interventionNames': ['Drug: MK-0954A', 'Drug: Placebo to MK-954H']}], 'interventions': [{'name': 'MK-0954A', 'type': 'DRUG', 'description': 'Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily', 'armGroupLabels': ['MK-0954A (L100/H12.5)']}, {'name': 'MK-954H', 'type': 'DRUG', 'otherNames': ['Preminent®'], 'description': 'Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily', 'armGroupLabels': ['MK-954H (L50/H12.5)']}, {'name': 'Placebo to MK-0954A', 'type': 'DRUG', 'description': 'Placebo tablet to match MK-0954A, once daily', 'armGroupLabels': ['MK-954H (L50/H12.5)']}, {'name': 'Placebo to MK-954H', 'type': 'DRUG', 'description': 'Placebo tablet to match MK-954H, once daily', 'armGroupLabels': ['MK-0954A (L100/H12.5)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}