A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

February 4, 2015 updated by: Merck Sharp & Dohme LLC

A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
  • Patient is male or female >=18 and <= 65 years of age
  • Patient understands the study procedures and alternative treatments available
  • Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

  • Patient has a history or presence of a major psychiatric disorder
  • Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
  • Patient has a history of seizures or is at high risk of developing seizures
  • Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
  • Patient has diabetes mellitus as defined by medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Arm 1: MK0364 Pbo capsules once daily
Placebo capsules once daily. Treatment for 52 weeks
Experimental: 2
Arm 2: MK0364 0.5 mg capsule once daily
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
Experimental: 3
Arm 3: MK0364 1 mg capsule once daily
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
Experimental: 4
Arm 4: MK0364 2 mg capsule once daily
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight at 52 weeks, safety and tolerability.
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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