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

This study has been completed.

First Received on July 6, 2006. Last Updated on August 31, 2007 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00349635

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: Metformin and Metformin + Fenofibrate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Procetofen Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Weight

Secondary Outcome Measures:

Waist and hip circumference

Estimated Enrollment:	148
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	30 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349635

Locations

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

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00349635 History of Changes
Other Study ID Numbers:	C LF23-0121 04 01, 2004-001731-28
Study First Received:	July 6, 2006
Last Updated:	August 31, 2007
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by Solvay Pharmaceuticals:

Weight loss and diet.

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Metformin

Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012