A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
- Registration Number
- NCT00420589
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- Patient is male or female >=18 and <= 65 years of age
- Patient understands the study procedures and alternative treatments available
- Patient is able to read, understand and complete study questionnaires
Exclusion Criteria
- Patient has a history or presence of a major psychiatric disorder
- Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- Patient has a history of seizures or is at high risk of developing seizures
- Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
- Patient has diabetes mellitus as defined by medical history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 taranabant Arm 2: MK0364 0.5 mg capsule once daily 3 taranabant Arm 3: MK0364 1 mg capsule once daily 4 taranabant Arm 4: MK0364 2 mg capsule once daily
- Primary Outcome Measures
Name Time Method Body weight at 52 weeks, safety and tolerability. 52 weeks
- Secondary Outcome Measures
Name Time Method Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks. 52 weeks