A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00349635
Collaborator
(none)
148
3
49.3
Study Details
Study Description
Brief Summary
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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.
Study Start Date
:
Oct 1, 2004
Outcome Measures
Primary Outcome Measures
- Weight []
Secondary Outcome Measures
- Waist and hip circumference []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 1 | Helsinki | Finland | ||
| 2 | Site 3 | Kuopio | Finland | ||
| 3 | Site 2 | Oulu | Finland |
Sponsors and Collaborators
- Solvay Pharmaceuticals
Investigators
- Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00349635
Other Study ID Numbers:
- C LF23-0121 04 01
- 2004-001731-28
First Posted:
Jul 7, 2006
Last Update Posted:
Sep 3, 2007
Last Verified:
Aug 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: