A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Metformin and Metformin + Fenofibrate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Summary
To investigate the effect on body weight of a combination fenofibrate and metformin on top of
a moderate balanced calorie-deficit diet.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Weight
Secondary outcome: Waist and hip circumference
Eligibility
Minimum age: 30 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Site 1, Helsinki, Finland
Site 2, Oulu, Finland
Site 3, Kuopio, Finland
Additional Information
Starting date: October 2004
Last updated: August 31, 2007
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