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

NCT00703755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2288

Last updated 2008-06-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2004-06-30
Completion
2004-06-30

Countries

  • Canada
  • Finland
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703755 on ClinicalTrials.gov