An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)

Phase 2

Completed

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT00131430
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to determine the safety and efficacy of an investigational drug in patients with obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-18
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea).

Exclusion Criteria

• Patients with serious or unstable current or past medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
After 24 weeks, body weight, safety, and tolerability	After 24 weeks

Secondary Outcome Measures

Name	Time	Method
After 80 weeks, body weight	After 80 weeks