A 1-Year Study of an Investigational Drug in Obese Patients - Full Text View

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 II Phase III

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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:

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 ]

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092872

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_031, MK0557-012
First Received:	September 23, 2004
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00092872
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on October 09, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092872