Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00856960
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2009-02-27', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren', 'timeFrame': '2-5 hours post dose of study drug'}], 'secondaryOutcomes': [{'measure': 'change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan', 'timeFrame': '2-5 hours post dose of study drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is in generally good health\n* Subject is willing to avoid unaccustomed strenuous exercise during the study\n* Subject agrees to consume ONLY the study-specified diet during all domiciled periods\n* Subject has been a non-smoker for at least 3 months prior to study\n* Subject will refrain from smoking or using any tobacco products during the study\n* Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study\n\nExclusion Criteria:\n\n* Subject has contraindication to MRI scans\n* Subject has a history of stroke, seizure, or major neurological disorders\n* Subject uses illicit drugs or has a history of drug/alcohol abuse\n* Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks\n* Subject has a history of multiple and/or severe allergies to drugs or food'}, 'identificationModule': {'nctId': 'NCT00856960', 'briefTitle': 'The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '0000-127'}, 'secondaryIdInfos': [{'id': '127'}, {'id': '2009_554'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Aliskiren 600 mg', 'interventionNames': ['Drug: Aliskiren', 'Drug: Comparator: Placebo to Losartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Aliskiren 150 mg', 'interventionNames': ['Drug: Aliskiren', 'Drug: Comparator: Placebo to Aliskiren', 'Drug: Comparator: Placebo to Losartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Losartan 100 mg', 'interventionNames': ['Drug: Comparator: Losartan', 'Drug: Comparator: Placebo to Aliskiren']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo to Aliskiren', 'Drug: Comparator: Placebo to Losartan']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.', 'armGroupLabels': ['1']}, {'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period.', 'armGroupLabels': ['2']}, {'name': 'Comparator: Losartan', 'type': 'DRUG', 'description': 'Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.', 'armGroupLabels': ['3']}, {'name': 'Comparator: Placebo to Aliskiren', 'type': 'DRUG', 'description': 'Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.', 'armGroupLabels': ['2', '3', '4']}, {'name': 'Comparator: Placebo to Losartan', 'type': 'DRUG', 'description': 'Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.', 'armGroupLabels': ['1', '2', '4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}