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

Phase 3TerminatedNCT00131391

Merck Sharp & Dohme LLC2,400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,400

Conditions

Obesity

Interventions

Comparator: taranabantDRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Comparator: placeboDRUG

Placebo capsule once daily . 52 week treatment period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Decreases body weight; prevention of weight regain; safety and tolerability

Time frame: 2 Years

Secondary Outcomes

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

Time frame: 2 Years

Data from ClinicalTrials.gov

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