A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092872
First received: September 23, 2004
Last updated: February 19, 2014
Last verified: February 2014
  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:


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

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: 359
Study Start Date: November 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  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
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: NCT00092872

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092872     History of Changes
Other Study ID Numbers: 0557-012, MK0557-012, 2004_031
Study First Received: September 23, 2004
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 30, 2014