A 2-Year Study of an Investigational Drug in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092859
First received: September 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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


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:


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

Primary Outcome Measures:
  • Body weight after 1 year of treatment. Safety and tolerability for 2 years. [ Time Frame: After 1 & 2 years of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durability of weight loss over two years. [ Time Frame: Over two years. ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: September 2003
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092859

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092859     History of Changes
Other Study ID Numbers: 2004_030, MK0557-011
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 April 23, 2014