A Two Year Safety and Efficacy Study in Obese Patients

Official Title: “A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension”

A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Intervention(s) in this Clinical Trial

• Drug: taranabant
  • taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
• Drug: Comparator: Placebo
  • Placebo capsule once daily. 52 week treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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.
• 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.
• 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.

Primary Measures

• Decreases body weight; safety and tolerability
  • Time Frame: 156 Weeks
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00131404

Study ID Number: 2005_031

ClinicalTrials.gov Identifier: NCT00131404

Health Authority: United States: Food and Drug Administration