Peripheral Arterial DiseasePhase 3NCT01367145
OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
A Phase 3 study testing OMACOR in people with Peripheral Arterial Disease, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- OMACOR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Vienna, 1090
About this study
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
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- OMACOR, Placebo
- Keywords
- OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function
- Medical subject headings
- Peripheral Arterial Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMACORDrug
4 capsules OMACOR 1g per day
PlaceboDrug
4 capsules placebo per day
| Study group | Role | What they receive |
|---|---|---|
| Omacor | Active comparator | Not described Receives: Drug: OMACOR |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline endothelial function to 3 months
measured by flow mediated vasodilation
Measured: baseline, 3 months
Secondary outcomes (7)
change from baseline endothelial function to six months
Measured: baseline, 6 months (3 months after treatment cessation)
change of walking distance (maximum/pain-free)from baseline to three months and six months
Measured: baseline, 3, 6 months
change of inflammatory markers from baseline to one, three and six months
Measured: baseline, 1, 3, 6 months
change of pulse wave velocity from baseline to one, three and six months
Measured: baseline, 1, 3, 6 months
bleeding events
Measured: 1, 3, 6 months
liver enzymes changes
Measured: baseline, 1,3,6 months
change of platelet activation from baseline to one, three and six months
Measured: baseline, 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Steiner, Medical University of Vienna
- Investigators
- Sabine Steiner, Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367145
- Sponsor's protocol ID
- OMACOR II - 2011
- Status last verified
- Aug 2014
- First submitted
- 9 May 2011
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01367145
- Acronym / sponsor ID
- OMACOR II - 2011
- Conditions
- Peripheral Arterial Disease
- Keywords
- OMEGA-3 polyunsaturated fatty-acids, Peripheral Arterial Disease, Endothelial Function, Inflammation, Platelet Function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omacor | Active comparator | Drug: OMACOR |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMACOR4 capsules OMACOR 1g per day | Drug | Omacor |
| Placebo4 capsules placebo per day | Drug | Placebo |
Primary outcome
change from baseline endothelial function to 3 months
Time frame: baseline, 3 months
measured by flow mediated vasodilation
7 secondary outcomes
change from baseline endothelial function to six months
Time frame: baseline, 6 months (3 months after treatment cessation)
change of walking distance (maximum/pain-free)from baseline to three months and six months
Time frame: baseline, 3, 6 months
change of inflammatory markers from baseline to one, three and six months
Time frame: baseline, 1, 3, 6 months
change of pulse wave velocity from baseline to one, three and six months
Time frame: baseline, 1, 3, 6 months
bleeding events
Time frame: 1, 3, 6 months
liver enzymes changes
Time frame: baseline, 1,3,6 months
change of platelet activation from baseline to one, three and six months
Time frame: baseline, 1, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Steiner, Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMACOR in people with Peripheral Arterial Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline endothelial function to 3 months (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.