An Eighteen Month Efficacy and Safety Study in Obese Patients

Verified by: Merck, October 2009
First Received: August 16, 2005 | Last Updated: October 6, 2009 | Phase: Phase 2/Phase 3 | Start Date: September 2005
Overall Status: Completed | Estimated Enrollment: 500
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A study to determine the safety and efficacy of an investigational drug in patients with obesity...

Brief Summary

Official Title: “An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

  • Drug: taranabant

Outcome Measures for this Clinical Trial

Primary Measures

  • After 24 weeks, body weight, safety, and tolerability
    • Time Frame: After 24 weeks
      Safety Issue?: Yes

Secondary Measures

  • After 80 weeks, body weight
    • Time Frame: After 80 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00131430

Study ID Number: 2005_044

ClinicalTrials.gov Identifier: NCT00131430

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00131430