A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

Phase 3

Terminated

• Conditions: Obesity
• Interventions: Drug: taranabant

• Registration Number: NCT00131404
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-18
• Study Start: 2005-09
• Primary Completion: 2007-02
• Study Completion: 2008-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

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

Inclusion Criteria

• Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/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

Arm && Interventions

Group	Intervention	Description
Phase A/B: Arm 2	taranabant	Phase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.
Phase A/B: Arm 3	taranabant	Phase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily.
Phase A/B: Arm 4	taranabant	Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily.
Phase A/B: Arm 5	taranabant	Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.

Primary Outcome Measures

Name	Time	Method
Decreases body weight; safety and tolerability	156 Weeks

Secondary Outcome Measures

Name	Time	Method
Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity	156 Weeks