An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
- Registration Number
- NCT00384605
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- 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
- Stable weight (+/-3 kg) for at least 3 months prior to study start
Exclusion Criteria
- History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
- Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 placebo Arm 4: Pbo capsule once daily. 2 taranabant Arm 2: MK0364 1 mg capsule once daily 1 taranabant Arm 1: MK0364 2 mg capsule once daily 3 taranabant Arm 3: MK0364 0.5 mg capsule once daily.
- Primary Outcome Measures
Name Time Method Body weight after 52 weeks of treatment 52 weeks
- Secondary Outcome Measures
Name Time Method Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment 52 weeks