drugset / Trial / NCT01367145

OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

NCT01367145

Phase 3 Completed 71 enrolled Medical University of Vienna
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD. Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion. Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound. Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.

Timeline

Start
2011-01
Primary completion
2013-11
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lovaza Other / unclassified 1 g Oral