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A Study of MK0364 in Obese Patients (0364-014)(TERMINATED)

This study has been terminated.
(The overall profile does not support development for obesity)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00131391
First received: August 16, 2005
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.


Condition Intervention Phase
Obesity
 Drug: Comparator: 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 (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Decreases body weight; prevention of weight regain; safety and tolerability [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 2400
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: February 2008 (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 Part B will remain in the same treatment arm they were assigned to in Part 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 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily.
 Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 3
Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily.
 Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
Drug: Comparator: placebo
Placebo capsule once daily . 52 week treatment period.
Experimental: Phase A/B: Arm 4
Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily.
 Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 5
Phase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily.
 Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
Experimental: Phase A/B: Arm 6
Phase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily.
 Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 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:

  • Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria:

  • History of major psychiatric disorder
  • History of seizures or at high risk of developing seizures
  • Blood pressure greater than 160/100
  • Fasting blood glucose greater than 126 mg/dL
  • Triglycerides greater than 600 mg/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131391

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00131391     History of Changes
Other Study ID Numbers: MK-0364-014, 2005_034
Study First Received: August 16, 2005
Last Updated: May 28, 2013
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 June 18, 2013