An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients

Official Title: “A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension”

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Intervention(s) in this Clinical Trial

• Drug: Comparator: taranabant
  • taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
• Drug: Comparator: placebo
  • Placebo capsule once daily. Treatment for 52 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: MK0364 2 mg capsule once daily
• Experimental: 2
  • Arm 2: MK0364 1 mg capsule once daily
• Experimental: 3
  • Arm 3: MK0364 0.5 mg capsule once daily.
• Placebo Comparator: 4
  • Arm 4: Pbo capsule once daily.

Primary Measures

• Body weight after 52 weeks of treatment
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female, 18 years of age or older, with Body Mass Index (BMI) 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). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
• Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion Criteria:

• History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
• Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384605

Study ID Number: 2006_513

ClinicalTrials.gov Identifier: NCT00384605

Health Authority: United States: Food and Drug Administration