Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-09 @ 5:34 AM
Study NCT ID:
NCT00887250
Status:
COMPLETED
Last Update Posted:
2009-07-14
First Post:
2009-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Antihypertensive Efficacy of MK0954
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Executive Vice President, Clinical and Quantitative Sciences', 'organization': 'Merck & Co., Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Safety has been reported in the literature.'}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 12 weeks (24 hours post dose)', 'description': 'Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}, {'type': 'SECONDARY', 'title': 'Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'title': 'Category I', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Category II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Category III', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours post dose at Week 6', 'description': 'Patients with trough SiDBP \\<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}, {'type': 'SECONDARY', 'title': 'Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'title': 'Category I', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Category II', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Category III', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours post dose at Week 12', 'description': 'Patients with trough SiDBP \\<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '-7.9', 'spread': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 6 weeks (24 hours post dose)', 'description': 'Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.1', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '8.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 6 weeks (24 hours post dose)', 'description': 'Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '-10.1', 'spread': '8.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 12 weeks (6 hours post dose)', 'description': 'Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'FG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Patient uncooperative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited at 22 sites in the United States. Prime Therapy Period: December, 1991 to August, 1992.', 'preAssignmentDetails': 'Patients could be randomized after the 4-week placebo baseline period if their mean sitting diastolic blood pressure (SiDBP) was 95-115 mm Hg and ≤7 mm Hg from the mean SiDBP after 2 weeks of placebo therapy'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Losartan placebo orally once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Losartan 50 mg', 'description': 'Losartan 50 mg orally once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Losartan 50/100 mg', 'description': 'Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '78'}, {'value': '53.2', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '75'}, {'value': '55.1', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '76'}, {'value': '54.0', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Oriental', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sitting Diastolic Blood Pressure (SiDBP)', 'classes': [{'categories': [{'measurements': [{'value': '101.3', 'groupId': 'BG000', 'lowerLimit': '95', 'upperLimit': '115'}, {'value': '102.2', 'groupId': 'BG001', 'lowerLimit': '95', 'upperLimit': '113'}, {'value': '102.2', 'groupId': 'BG002', 'lowerLimit': '95', 'upperLimit': '114'}, {'value': '101.9', 'groupId': 'BG003', 'lowerLimit': '95', 'upperLimit': '114'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '1992-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-08', 'studyFirstSubmitDate': '2009-04-22', 'resultsFirstSubmitDate': '2009-05-07', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-07', 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1992-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12', 'timeFrame': 'At baseline and at 12 weeks (24 hours post dose)', 'description': 'Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12'}], 'secondaryOutcomes': [{'measure': 'Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6', 'timeFrame': '24 hours post dose at Week 6', 'description': 'Patients with trough SiDBP \\<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.'}, {'measure': 'Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12', 'timeFrame': '24 hours post dose at Week 12', 'description': 'Patients with trough SiDBP \\<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.'}, {'measure': 'Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6', 'timeFrame': 'At baseline and at 6 weeks (24 hours post dose)', 'description': 'Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6'}, {'measure': 'Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6', 'timeFrame': 'At baseline and at 6 weeks (24 hours post dose)', 'description': 'Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6'}, {'measure': 'Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12', 'timeFrame': 'At baseline and at 12 weeks (6 hours post dose)', 'description': 'Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)\n* Patient has no medical problems or treatments that might effect their blood pressure\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Patient has secondary hypertension or malignant hypertension\n* Sitting systolic blood pressure \\> 210 mm Hg\n* History of stroke\n* History of myocardial infarction with in past year\n* Current or prior history of heart failure\n* Known hypersensitivity to losartan\n* Prior exposure to losartan\n* Patients known to be HIV positive\n* Patient is abusing or has abused alcohol or other drugs within the past 4 years'}, 'identificationModule': {'nctId': 'NCT00887250', 'briefTitle': 'A Study to Investigate the Antihypertensive Efficacy of MK0954', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to', 'orgStudyIdInfo': {'id': '2009_580'}, 'secondaryIdInfos': [{'id': 'MK0954-050'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Losartan 50 mg for 12 weeks', 'interventionNames': ['Drug: losartan potassium']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Losartan 50 mg titrated to 100 mg after 6 weeks', 'interventionNames': ['Drug: Comparator: losartan']}], 'interventions': [{'name': 'losartan potassium', 'type': 'DRUG', 'otherNames': ['MK0954'], 'description': '50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.', 'armGroupLabels': ['2']}, {'name': 'Comparator: losartan', 'type': 'DRUG', 'otherNames': ['MK0954'], 'description': '50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.', 'armGroupLabels': ['3']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo to Losartan', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Executive Vice President, Clinical and Quantitative Sciences', 'oldOrganization': 'Merck & Co., Inc.'}}}}