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
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: 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 August 28, 2014