An Eighteen Month Efficacy and Safety Study in Obese Patients
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00131430
First received: August 16, 2005
Last updated: October 6, 2009
Last verified: October 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 16, 2005 | ||||
| Last Updated Date | October 6, 2009 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
After 24 weeks, body weight, safety, and tolerability [ Time Frame: After 24 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00131430 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
After 80 weeks, body weight [ Time Frame: After 80 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Eighteen Month Efficacy and Safety Study in Obese Patients | ||||
| Official Title ICMJE | An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients | ||||
| Brief Summary | A study to determine the safety and efficacy of an investigational drug in patients with obesity. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Obesity and Obesity-related Medical Conditions | ||||
| Intervention ICMJE | Drug: taranabant
Other Name: MK0364 |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00131430 | ||||
| Other Study ID Numbers ICMJE | 2005_044, MK0364-020 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Merck | ||||
| Verification Date | October 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||