A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)
Phase 3
Completed
- Conditions
- Obesity
- Registration Number
- NCT00092859
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
- Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) 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 Body weight after 1 year of treatment. Safety and tolerability for 2 years. After 1 & 2 years of treatment
- Secondary Outcome Measures
Name Time Method Durability of weight loss over two years. Over two years.