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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2012

At a glance

  • Drugs Ezetimibe; Fenofibrate/pravastatin; Simvastatin
  • Indications Hypercholesterolaemia; Hyperlipidaemia
  • Focus Therapeutic Use
  • Acronyms PREFED
  • Sponsors SMB
  • Most Recent Events

    • 05 Jul 2012 Actual end date (7 Sep 2008) added as reported by European Clinical Trials Database.
    • 05 Jul 2012 New source identified and integrated (European Clinical Trials Database, EudraCT2006-006557-28).
    • 05 Jul 2012 Planned number of patients 480, additional drug company, trial locations, actual initiation date (7 May 2007) added and official title amended as reported by European Clinical Trials Database.
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