A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
Phase 3
Completed
- Conditions
- Obesity
- Registration Number
- NCT00092872
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 359
Inclusion Criteria
- Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.
Exclusion Criteria
- Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability. After 1 year of treatment Body weight after 1 year of treatment. After 1 year of treatment
- Secondary Outcome Measures
Name Time Method Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years After 2 years