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

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:
NCT00131391
First received: August 16, 2005
Last updated: May 1, 2014
Last verified: May 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131391

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00131391     History of Changes
Other Study ID Numbers: 0364-014, 2005_034
Study First Received: August 16, 2005
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014