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| Tracking Information | |||||
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| First Received Date ICMJE | January 23, 2002 | ||||
| Last Updated Date | April 17, 2009 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in body weight at 1 year. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00029835 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Metabolic parameters | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Obese Patients With Untreated Dyslipidemias | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias | ||||
| Brief Summary | To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Rimonabant (SR141716) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1033 | ||||
| Completion Date | November 2003 | ||||
| Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada, Finland, Italy, Spain, Sweden, Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00029835 | ||||
| Responsible Party | ICD Study Director, sanofi-aventis | ||||
| Study ID Numbers ICMJE | EFC4735 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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