Acceptability of a Fixed Combination of Fenofibrate and Metformin
Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00348725
Collaborator
(none)
69
25
2.8
Study Details
Study Description
Brief Summary
The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia
Study Start Date
:
Apr 1, 2005
Outcome Measures
Primary Outcome Measures
- Quotation by Visual Numeric Rating Scale before and after 4-week treatment []
Secondary Outcome Measures
- Assessment of safety by reporting of Adverse Events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with type 2 diabetes mellitus and dyslipidemia.
Exclusion Criteria:
- Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose
300 mg/dL - Triglycerides > 500 mg/dL
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 24 | Anzin | France | ||
| 2 | Site 23 | Bachant | France | ||
| 3 | Site 21 | Baune | France | ||
| 4 | Site 32 | Bersee | France | ||
| 5 | Site 34 | Briollay | France | ||
| 6 | Site 27 | Denain | France | ||
| 7 | Site 28 | Denain | France | ||
| 8 | Site 5 | Le Temple de Bretagne | France | ||
| 9 | Site 29 | Nantes | France | ||
| 10 | Site 2 | Nantes | France | ||
| 11 | Site 8 | Nantes | France | ||
| 12 | Site 9 | Nantes | France | ||
| 13 | Site 1 | Nort sur Erdre | France | ||
| 14 | Site 13 | Parcay les Pins | France | ||
| 15 | Site 26 | Quarouble | France | ||
| 16 | Site 7 | Saint Aignan le Grand | France | ||
| 17 | Site 4 | Saint Herblain | France | ||
| 18 | Site 30 | Saint-Amand | France | ||
| 19 | Site 11 | Sautron | France | ||
| 20 | Site 17 | Segre | France | ||
| 21 | Site 10 | St Etienne de Montluc | France | ||
| 22 | Site 33 | Thiant | France | ||
| 23 | Site 12 | Thouars | France | ||
| 24 | Site 25 | Vieux Conde | France | ||
| 25 | Site 20 | Vihiers | France |
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:
NCT00348725
Other Study ID Numbers:
- C LF23-0121 04 02
First Posted:
Jul 6, 2006
Last Update Posted:
Sep 3, 2007
Last Verified:
Aug 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: