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

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ClinicalTrials.gov Identifier: NCT00131430
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Obesity and Obesity-related Medical Conditions Drug: taranabant Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients
Study Start Date : August 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Intervention Details:
    Drug: taranabant
    Other Name: MK0364


Primary Outcome Measures :
  1. After 24 weeks, body weight, safety, and tolerability [ Time Frame: After 24 weeks ]

Secondary Outcome Measures :
  1. After 80 weeks, body weight [ Time Frame: After 80 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131430


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00131430     History of Changes
Other Study ID Numbers: 0364-020
2005_044
MK-0364-020
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: March 2016