A Study of MK0364 in Obese Patients (0364-014)

Phase 3

Terminated

• Conditions: Obesity

• Registration Number: NCT00131391
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-18
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria

• History of major psychiatric disorder
• History of seizures or at high risk of developing seizures
• Blood pressure greater than 160/100
• Fasting blood glucose greater than 126 mg/dL
• Triglycerides greater than 600 mg/dL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decreases body weight; prevention of weight regain; safety and tolerability	2 Years

Secondary Outcome Measures

Name	Time	Method
Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity	2 Years