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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482638
First received: June 1, 2007
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.


Condition Intervention Phase
Obesity
Drug: MK0493
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Study Start Date: March 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482638

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482638     History of Changes
Other Study ID Numbers: 2007_571
Study First Received: June 1, 2007
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 19, 2014