- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384605
An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
March 12, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Arm 1: MK0364 2 mg capsule once daily
|
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily.
Treatment for 52 weeks.
|
Experimental: 2
Arm 2: MK0364 1 mg capsule once daily
|
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily.
Treatment for 52 weeks.
|
Experimental: 3
Arm 3: MK0364 0.5 mg capsule once daily.
|
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily.
Treatment for 52 weeks.
|
Placebo Comparator: 4
Arm 4: Pbo capsule once daily.
|
Placebo capsule once daily.
Treatment for 52 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight after 52 weeks of treatment
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
October 3, 2006
First Submitted That Met QC Criteria
October 3, 2006
First Posted (Estimate)
October 6, 2006
Study Record Updates
Last Update Posted (Estimate)
March 13, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Body Weight
- Obesity
- Overweight
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide
Other Study ID Numbers
- 0364-037
- 2006_513
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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