- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00420589
A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
February 4, 2015 updated by: Merck Sharp & Dohme LLC
A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- Patient is male or female >=18 and <= 65 years of age
- Patient understands the study procedures and alternative treatments available
- Patient is able to read, understand and complete study questionnaires
Exclusion Criteria:
- Patient has a history or presence of a major psychiatric disorder
- Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- Patient has a history of seizures or is at high risk of developing seizures
- Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
- Patient has diabetes mellitus as defined by medical history
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Arm 1: MK0364 Pbo capsules once daily
|
Placebo capsules once daily.
Treatment for 52 weeks
|
Experimental: 2
Arm 2: MK0364 0.5 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 1 mg capsule once daily
|
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily.
Treatment for 52 weeks.
|
Experimental: 4
Arm 4: MK0364 2 mg capsule once daily
|
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily.
Treatment for 52 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight at 52 weeks, safety and tolerability.
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
February 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
January 5, 2007
First Submitted That Met QC Criteria
January 10, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
February 5, 2015
Last Update Submitted That Met QC Criteria
February 4, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- 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
- 0364-012
- 2006_512
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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