NCT00703755

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,288 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Patients With Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Fenofibrate /Metformin	fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
DRUG	Fenofibrate /Metformin	fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
DRUG	Fenofibrate /Metformin	fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
DRUG	Fenofibrate /Metformin	fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
DRUG	Fenofibrate /Metformin	fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
DRUG	Fenofibrate /Metformin	fenofibrate placebo + metformin 850 mg bid (F0-M1700)
DRUG	Placebo	Placebo

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2008-06-23
• Last updated: 2008-06-25

Locations

101 sites across 9 countries: Canada, Finland, Hungary, Italy, Netherlands, Norway, Poland, Romania, Sweden