An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)
June 6, 2016 updated by: Merck Sharp & Dohme LLC
An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients
A study to determine the safety and efficacy of an investigational drug in patients with obesity.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 2
- 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:
- Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
After 24 weeks, body weight, safety, and tolerability
Time Frame: After 24 weeks
|
After 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
After 80 weeks, body weight
Time Frame: After 80 weeks
|
After 80 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
August 1, 2005
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
August 16, 2005
First Submitted That Met QC Criteria
August 17, 2005
First Posted (Estimate)
August 18, 2005
Study Record Updates
Last Update Posted (Estimate)
June 7, 2016
Last Update Submitted That Met QC Criteria
June 6, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- 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
- 0364-020
- 2005_044
- MK-0364-020
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.