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Sponsored by: |
Solvay Pharmaceuticals |
---|---|
Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00703755 |
The purpose of this study was to study the effect of different combinations of fenofibrate and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to determine the dose combination allowing normalization of MetS patients.
Condition | Intervention | Phase |
---|---|---|
Patients With Metabolic Syndrome |
Drug: Fenofibrate /Metformin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome. |
Enrollment: | 2288 |
Study Start Date: | March 2003 |
Study Completion Date: | June 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
|
2: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
|
3: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
|
4: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
|
5: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
|
6: Experimental |
Drug: Fenofibrate /Metformin
fenofibrate placebo + metformin 850 mg bid (F0-M1700)
|
7: Placebo Comparator |
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
known Type 1 diabetes, or treated type 2 diabetes [25], [26];
presenting with the following disease or conditions:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Bruno Fraitag ) |
Study ID Numbers: | CFEN0203 |
Study First Received: | June 20, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00703755 |
Health Authority: | Canada: Health Canada |
Diabetes Hypertriglyceridaemia Metabolic Syndrome |
Hypertriglyceridemia Metformin Diabetes Mellitus Procetofen |
Antimetabolites Hypoglycemic Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Antilipemic Agents Syndrome Physiological Effects of Drugs Pharmacologic Actions |