A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.

August 31, 2007 updated by: Solvay Pharmaceuticals

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.

To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

148

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Site 1
      • Kuopio, Finland
        • Site 3
      • Oulu, Finland
        • Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weight

Secondary Outcome Measures

Outcome Measure
Waist and hip circumference

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2007

Last Update Submitted That Met QC Criteria

August 31, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C LF23-0121 04 01
  • 2004-001731-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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