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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00131404
First received: August 16, 2005
Last updated: March 5, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

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

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 ] [ Designated as safety issue: No ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131404

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00131404     History of Changes
Other Study ID Numbers: 0364-015, 2005_031
Study First Received: August 16, 2005
Last Updated: March 5, 2014
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 April 17, 2014