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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 23, 2004
Last updated: June 30, 2014
Last verified: June 2014
This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.

Condition Intervention Phase
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

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
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00092859

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092859     History of Changes
Other Study ID Numbers: 0557-011  MK0557-011  2004_030 
Study First Received: September 23, 2004
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration processed this record on December 09, 2016