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A 1-Year Study of an Investigational Drug in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092872
First received: September 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.


Condition Intervention Phase
Obesity
 Drug: MK0557
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Body weight after 1 year of treatment. [ Time Frame: After 1 year of treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability. [ Time Frame: After 1 year of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2003
Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

Exclusion Criteria:

  • Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092872

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092872     History of Changes
Other Study ID Numbers: 2004_031, MK0557-012
Study First Received: September 23, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013