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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092859
First received: September 23, 2004
Last updated: December 30, 2016
Last verified: December 2016
  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
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 ]

Secondary Outcome Measures:
  • Durability of weight loss over two years. [ Time Frame: Over two years. ]

Enrollment: 1500
Study Start Date: August 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00092859

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092859     History of Changes
Other Study ID Numbers: 0557-011  MK0557-011  2004_030 
Study First Received: September 23, 2004
Last Updated: December 30, 2016

ClinicalTrials.gov processed this record on March 01, 2017