Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-04 @ 1:45 PM
Study NCT ID:
NCT00131404
Status:
TERMINATED
Last Update Posted:
2015-02-05
First Post:
2005-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Canada', 'Chile', 'Czechia', 'Denmark', 'Finland', 'Germany', 'Hong Kong', 'Malaysia', 'Mexico', 'Netherlands', 'New Zealand', 'Norway', 'Peru', 'Spain', 'Switzerland', 'Taiwan', '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': 2400}}, 'statusModule': {'whyStopped': 'The overall profile does not support development for obesity', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2005-08-16', 'studyFirstSubmitQcDate': '2005-08-17', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreases body weight; safety and tolerability', 'timeFrame': '156 Weeks'}], 'secondaryOutcomes': [{'measure': 'Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity', 'timeFrame': '156 Weeks'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '20157323', 'type': 'RESULT', 'citation': 'Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea\n\nExclusion Criteria:\n\n* Patients with serious or unstable current or past medical conditions'}, 'identificationModule': {'nctId': 'NCT00131404', 'briefTitle': 'A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension', 'orgStudyIdInfo': {'id': '0364-015'}, 'secondaryIdInfos': [{'id': '2005_031'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Phase A/B: Arm 1', 'description': 'Phase A: Arm 1: MK0364 Pbo capsule once daily.\n\nPhase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.', 'interventionNames': ['Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase A/B: Arm 2', 'description': 'Phase A: Arm 2: MK0364 2 mg capsule once daily.\n\nPhase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.', 'interventionNames': ['Drug: taranabant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase A/B: Arm 3', 'description': 'Phase A: Arm 3: MK0364 4 mg capsule once daily.\n\nPhase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3:\n\nMK0364 4 mg capsule once daily.', 'interventionNames': ['Drug: taranabant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase A/B: Arm 4', 'description': 'Phase A: Arm 4: MK0364 6 mg capsule once daily.\n\nPhase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4:\n\nMK0364 6 mg capsule once daily.', 'interventionNames': ['Drug: taranabant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase A/B: Arm 5', 'description': 'Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.', 'interventionNames': ['Drug: taranabant']}], 'interventions': [{'name': 'taranabant', 'type': 'DRUG', 'otherNames': ['MK0364'], 'description': 'taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.', 'armGroupLabels': ['Phase A/B: Arm 2', 'Phase A/B: Arm 3', 'Phase A/B: Arm 4', 'Phase A/B: Arm 5']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo capsule once daily. 52 week treatment period.', 'armGroupLabels': ['Phase A/B: Arm 1']}]}, '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'}}}}