Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)

November 13, 2019 updated by: Merck Sharp & Dohme LLC
To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is between 21 and 65 years
  • Patient is able to read and understand and complete study questionnaires
  • Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period

Exclusion Criteria:

  • Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
  • Patient is HIV positive as determined by medical history
  • Patient has undergone surgical treatment for obesity
  • Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
  • Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
  • Patient is currently a heavy consumer of alcohol (>2 drinks per day or >14 drinks per week [1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse

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

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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.

General Publications

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 (Actual)

May 12, 2004

Primary Completion (Actual)

October 29, 2004

Study Completion (Actual)

October 29, 2004

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 0493-008
  • 2007_571

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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Locations

3
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