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A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

This study has been terminated.
(The overall profile does not support development for obesity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131404
First Posted: August 18, 2005
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Condition Intervention Phase
Obesity Drug: taranabant Drug: Comparator: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

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

Primary Outcome Measures:
  • Decreases body weight; safety and tolerability [ Time Frame: 156 Weeks ]

Secondary Outcome Measures:
  • Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity [ Time Frame: 156 Weeks ]

Enrollment: 2400
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Phase A/B: Arm 1

Phase A: Arm 1: MK0364 Pbo capsule once daily.

Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.

Drug: Comparator: Placebo
Placebo capsule once daily. 52 week treatment period.
Experimental: Phase A/B: Arm 2

Phase A: Arm 2: MK0364 2 mg capsule once daily.

Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.

Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 3

Phase A: Arm 3: MK0364 4 mg capsule once daily.

Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3:

MK0364 4 mg capsule once daily.

Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 4

Phase A: Arm 4: MK0364 6 mg capsule once daily.

Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4:

MK0364 6 mg capsule once daily.

Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 5
Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.
Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Other Name: MK0364

  Eligibility

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 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/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
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): NCT00131404


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