A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Overview[ - collapse ][ - ]
| Purpose | To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet. |
|---|---|
| Condition | Obesity |
| Intervention | Drug: Metformin and Metformin + Fenofibrate |
| Phase | Phase 2 |
| Sponsor | Solvay Pharmaceuticals |
| Responsible Party | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00349635 |
| First Received | July 6, 2006 |
| Last Updated | August 31, 2007 |
| Last verified | August 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 6, 2006 |
|---|---|
| Last Updated Date | August 31, 2007 |
| Start Date | October 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Weight |
| Current Secondary Outcome Measures | Waist and hip circumference |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients. |
|---|---|
| Official Title | A Double-Blind, 3-Arm Study on Weight Loss With a Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Per Day Compared to Metformin 1,700 mg and to Placebo, at 6 Months, in Obese Patients, Followed by: A Double-Blind, 2-Arm Investigation of Weight-Loss Maintenance With the Same Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Compared to Placebo, at 6 Months, in the Responders. |
| Brief Summary | To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Obesity |
| Intervention | Drug: Metformin and Metformin + Fenofibrate |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 148 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Both genders, BMI ≥ 30 kg/m² and <40 kg/m². Exclusion Criteria: - Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level. |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Finland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00349635 |
|---|---|
| Other Study ID Numbers | C LF23-0121 04 01 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Solvay Pharmaceuticals |
| Study Sponsor | Solvay Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals |
| Verification Date | August 2007 |
Locations[ + expand ][ + ]
| Site 1 | Helsinki, Finland |
|---|---|
| Site 3 | Kuopio, Finland |
| Site 2 | Oulu, Finland |