A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

December 30, 2016 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients

This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study

Exclusion Criteria:

  • Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight after 1 year of treatment. Safety and tolerability for 2 years.
Time Frame: After 1 & 2 years of treatment
After 1 & 2 years of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability of weight loss over two years.
Time Frame: Over two years.
Over two years.

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

August 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 23, 2004

First Submitted That Met QC Criteria

September 27, 2004

First Posted (Estimate)

September 28, 2004

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0557-011
  • MK0557-011
  • 2004_030

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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