NCT00092859
Completed
Phase 3
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,500
- Primary Endpoint
- Body weight after 1 year of treatment. Safety and tolerability for 2 years.
Overview
Brief Summary
This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Body weight after 1 year of treatment. Safety and tolerability for 2 years.
Time Frame: After 1 & 2 years of treatment
Secondary Outcomes
- Durability of weight loss over two years.(Over two years.)
Investigators
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