ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092859
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Obesity Drug: MK0557 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005



Primary Outcome Measures :
  1. Body weight after 1 year of treatment. Safety and tolerability for 2 years. [ Time Frame: After 1 & 2 years of treatment ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092859


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092859     History of Changes
Other Study ID Numbers: 0557-011
MK0557-011
2004_030
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016