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

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.

Sponsored by:	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

MedlinePlus related topics:

Obesity Weight Control

ChemIDplus related topics:

Metformin Metformin hydrochloride Procetofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

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 2
	Oulu, Finland
	Site 3
	Kuopio, Finland

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators


Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information

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

Keywords provided by Solvay Pharmaceuticals:

Weight loss and diet.

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Metformin

Weight Loss

Body Weight Changes

Nutrition Disorders

Overweight

Overnutrition

Procetofen

Additional relevant MeSH terms:

Antimetabolites

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008