Trial record 7 of 224 for:    Open Studies | "Peripheral Arterial Disease"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01367145
First received: May 9, 2011
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Drug: OMACOR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    measured by flow mediated vasodilation


Secondary Outcome Measures:
  • change from baseline endothelial function to six months [ Time Frame: baseline, 6 months (3 months after treatment cessation) ] [ Designated as safety issue: No ]
  • change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • bleeding events [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: Yes ]
  • liver enzymes changes [ Time Frame: baseline, 1,3,6 months ] [ Designated as safety issue: Yes ]
  • change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omacor Drug: OMACOR
4 capsules OMACOR 1g per day
Placebo Comparator: Placebo Drug: Placebo
4 capsules placebo per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severity of disease: Rutherford category II or III - moderate to severe Stable intermittent claudication
  • Ankle Brachial Index<0.9
  • Age ≥18 years
  • Adequate PAD therapy according to current AHA guidelines

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
  • Inability to perform treadmill test
  • Dual antiplatelet therapy (aspirin and clopidogrel)
  • Previous myocardial infarction
  • Known liver diseases, except fatty liver
  • Known bleeding diathesis
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367145

Contacts
Contact: Alexandra Hammer, Dr. +43 1 40400 ext 4670 alexandra.hammer@meduniwien.ac.at
Contact: Sabine Steiner, Dr. +43 1 40400 ext 4670 sabine.steiner-boeker@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Internal Medicine II, Division of Angiology Recruiting
Vienna, Austria, 1090
Contact: Sabine Steiner, Dr.    +43 1 40400 ext 4670    sabine.steiner-boeker@meduniwien.ac.at   
Contact: Alexandra Hammer, Dr.    +43 1 40 400 ext 4670    alexandra.hammer@meduniwien.ac.at   
Principal Investigator: Sabine Steiner, Dr.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Steiner, Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Sabine Steiner, Medical University of Vienna, Department of Internal Medicin II, Division of Angiology
ClinicalTrials.gov Identifier: NCT01367145     History of Changes
Other Study ID Numbers: OMACOR II - 2011
Study First Received: May 9, 2011
Last Updated: June 3, 2011
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
OMEGA-3 polyunsaturated fatty-acids
Peripheral Arterial Disease
Endothelial Function
Inflammation
Platelet Function

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014