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

A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension

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

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Comparator: placebo; Drug: Comparator: taranabant

• Study Type: Interventional
• Enrollment (Actual): 2400
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Phase A/B; Arm 1; Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.	Drug: Comparator: placebo; Placebo capsule once daily . 52 week treatment period.
Experimental: Phase A/B: Arm 2; Phase A: Arm 2: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily.	Drug: Comparator: taranabant; taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.; Other Names: MK0364
Experimental: Phase A/B: Arm 3; Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily.	Drug: Comparator: placebo; Placebo capsule once daily . 52 week treatment period.; Drug: Comparator: taranabant; taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.; Other Names: MK0364
Experimental: Phase A/B: Arm 4; Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily.	Drug: Comparator: taranabant; taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.; Other Names: MK0364
Experimental: Phase A/B: Arm 5; Phase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily.	Drug: Comparator: taranabant; taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.; Other Names: MK0364
Experimental: Phase A/B: Arm 6; Phase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily.	Drug: Comparator: taranabant; taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.; Other Names: MK0364

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decreases body weight; prevention of weight regain; safety and tolerability	2 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 16, 2005
• First Submitted That Met QC Criteria: August 17, 2005
• First Posted (Estimate): August 18, 2005

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide
• Other Study ID Numbers: 0364-014; 2005_034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No