Clinical Trial Results:
A phase III, four-armed, randomised, double blind, parallel study to compare the efficacy and safety in type 2 diabetic patients with combined hyperlipidemia of a 12-week administration of Fenofibrate 160mg/Pravastatin 40mg combination versus Simvastatin 20mg in patients without Cardiovascular disease (CVD) (group 1) and of Fenofibrate 160mg/Pravastatin 40mg combination+Ezetimibe 10mg versus Simvastatin 20mg+Ezetimibe 10mg in patients with CVD (group 2), followed by a 12-week safety phase of Fenofibrate 160mg/Pravastatin 40mg combination in group 1 and of Fenofibrate 160mg/Pravastatin 40 mg combination+Ezetimibe 10mg in group 2.
Summary
|
|
EudraCT number |
2006-006557-28 |
Trial protocol |
FR HU DE |
Global completion date |
22 Dec 2008
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
01 Feb 2016
|
First version publication date |
23 Aug 2014
|
Other versions |
|
Summary report(s) |
Clinical study report summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.