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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 16, 2005
Last updated: November 27, 2013
Last verified: November 2013
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

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

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

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
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Please refer to this study by its identifier: NCT00131430

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

Responsible Party: Merck Sharp & Dohme Corp. 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 processed this record on April 27, 2016