An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00131430
First received: August 16, 2005
Last updated: November 27, 2013
Last verified: November 2013
  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 2
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: An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients

Resource links provided by NLM:


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

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: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: taranabant
    Other Name: MK0364
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Patients with serious or unstable current or past medical conditions.
  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: NCT00131430

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00131430     History of Changes
Other Study ID Numbers: 0364-020, 2005_044, MK-0364-020
Study First Received: August 16, 2005
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014