Status:
COMPLETED
Effects of Omacor and Aspirin on Platelet Function
Lead Sponsor:
Sanford Research
Conditions:
Healthy
Eligibility:
All Genders
21-60 years
Phase:
EARLY_PHASE1
Brief Summary
Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose ...
Detailed Description
Overview This study will explore the effects of 4 g/d of Omacor in healthy volunteers both with and without concomitant aspirin therapy. The study will utilize three different analytical approaches t...
Eligibility Criteria
Inclusion
- Subjects may be male or female and between the ages of 21 and 60,
- Non-smokers,
- Taking no medications, vitamin pills, nutritional supplements or herbal preparations.
Exclusion
- Subjects may not have a history of allergic reactions to aspirin, fish or fish oils.
- Birth control pills are not allowed.
- Subject cannot have an allergy to aspirin or to non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Naprosyn, Anaprox, others), indomethacin (Indocin), or ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), oxaprozin (Daypro), or tartrazine.
- Drinking more than three alcoholic beverages a day
- Having any of the following conditions:
- an ulcer or bleeding in the stomach,
- liver or kidney disease,
- bleeding or blood clotting disorder (e.g., hemophilia),
- congestive heart failure,
- fluid retention,
- heart disease,
- high blood pressure,
- gout,
- asthma,
- arthritis, or
- nasal polyps.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00688961
Start Date
June 1 2007
End Date
August 1 2007
Last Update
June 3 2008
Active Locations (1)
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1
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57105