A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

Study Overview
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Brief Summary
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To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

Official Title
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A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension

Conditions
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Obesity

Intervention / Treatment
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* Drug: taranabant
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Arm 1: MK0364 Pbo capsules once daily | Drug: Comparator: placebo<br>* Placebo capsules once daily. Treatment for 52 weeks<br>|
| Experimental: 2<br>Arm 2: MK0364 0.5 mg capsule once daily | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|
| Experimental: 3<br>Arm 3: MK0364 1 mg capsule once daily | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|
| Experimental: 4<br>Arm 4: MK0364 2 mg capsule once daily | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight at 52 weeks, safety and tolerability. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks. |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Weight regain, Weight maintenance