FindTrial
Sign In

OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION – A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL

OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION – A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018190-31-AT
Enrollment
Unknown
Registered
2010-07-14
Start date
2010-08-03
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral arterial disease (PAD) and intermittent claudication (IC)

Interventions

Trade Name: OMACOR - Kapseln Product Name: OMACOR - Kapseln Pharmaceutical Form: Capsule* INN or Proposed INN: Omacor CAS Number: 8000055007 Other descriptive name: OMEGA-3 MARINE TRIGLYCERIDES Concen

Sponsors

Medizinische Universität Wien, Univ.Klinik f.Innere Medizin II, Abt.f.Angiologie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Severity of disease: Rutherford category II or III – moderate to severe Stable intermittent claudication Ankle Brachial Index=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Current treatment with Omacor or other fish oil products Planned vascular intervention Known hypersensitivity to the study drug Rest pain or ischemic ulcer Exercise tolerance limited by factors other than PAD Unability to perform treadmill test Dual antiplatelet therapy (aspirin and clopidogrel) Previous myocardial infarction Women of childbearing potential who do not practice a safe contraception method Current participation in another intervention study. Previous participation in another study with an intervention within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Main Objective: the change in endothelial function measured by flow-mediated vasodilation (FMD) within 12 weeks of treatment;Secondary Objective: -pain-free walking distance (PFWD) -maximum walking distance (MWD) ;Primary end point(s): change in endothelial function measured by flow-mediated vasodilation (FMD) within 12 weeks of treatment—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026