Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00459004
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2007-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Japanese Dose-Response Study of Rimonabant in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-06', 'studyFirstSubmitDate': '2007-04-10', 'studyFirstSubmitQcDate': '2007-04-10', 'lastUpdatePostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absolute change in body weight from baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure'}, {'measure': 'Safety:adverse events, laboratory tests, ECGs'}, {'measure': 'Pharmacokinetics: SR141716 plasma trough concentrations'}]}, 'conditionsModule': {'keywords': ['weight loss'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary objective is to verify the dose-response relationship of rimonabant on body weight change.\n\nThe secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index ≥25 kg/m²\n* Viceral Fat Area ≥ 100 cm²\n* Diet therapy for more than 8 weeks before start of the placebo observation period\n* Stable weight (variation \\< ±3kg within 8 weeks before start of observation period)\n* At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension'}, 'identificationModule': {'nctId': 'NCT00459004', 'briefTitle': 'Japanese Dose-Response Study of Rimonabant in Obese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Dose-Response Relationship Study of SR141716 in Obese Patients', 'orgStudyIdInfo': {'id': 'DRI5747'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rimonabant (SR141716)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kohji SHIRAI, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toho University Sakura Medical Center, Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}