An Eighteen Month Efficacy and Safety Study in Obese Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00131430

Purpose

A study to determine the safety and efficacy of an investigational drug in patients with obesity.

Condition	Intervention	Phase
Obesity and Obesity-Related Medical Conditions	Drug: taranabant	Phase II

MedlinePlus related topics: Obesity

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients

Further study details as provided by Merck:

Primary Outcome Measures:

After 24 weeks, body weight, safety, and tolerability [ Time Frame: After 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

After 80 weeks, body weight [ Time Frame: After 80 weeks ] [ Designated as safety issue: No ]

Enrollment:	500
Study Start Date:	September 2005
Study Completion Date:	November 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea).

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131430

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:	2005_044, MK0364-020
Study First Received:	August 16, 2005
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00131430
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 January 16, 2009