Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00384605
Status:
TERMINATED
Last Update Posted:
2015-03-13
First Post:
2006-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Czechia', 'Denmark', 'Finland', 'France', 'Germany', 'New Zealand', 'Sweden', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521311', 'term': 'N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'whyStopped': 'The overall profile does not support development for obesity', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2006-10-03', 'studyFirstSubmitQcDate': '2006-10-03', 'lastUpdatePostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight after 52 weeks of treatment', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea\n* Stable weight (+/-3 kg) for at least 3 months prior to study start\n\nExclusion Criteria:\n\n* History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures\n* Screening systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg'}, 'identificationModule': {'nctId': 'NCT00384605', 'briefTitle': 'An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension', 'orgStudyIdInfo': {'id': '0364-037'}, 'secondaryIdInfos': [{'id': '2006_513'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: MK0364 2 mg capsule once daily', 'interventionNames': ['Drug: taranabant']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Arm 2: MK0364 1 mg capsule once daily', 'interventionNames': ['Drug: taranabant']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Arm 3: MK0364 0.5 mg capsule once daily.', 'interventionNames': ['Drug: taranabant']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Arm 4: Pbo capsule once daily.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'taranabant', 'type': 'DRUG', 'description': 'taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo capsule once daily. Treatment for 52 weeks.', 'armGroupLabels': ['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'}}}}