NCT00688961

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 of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started Jun 2007

Shorter than P25 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

2 months

First QC Date

May 30, 2008

Last Update Submit

June 2, 2008

Conditions

Healthy

Keywords

omega-3 fatty acidsaspirinplatelet aggregationHealthy volunteers; no disease

Outcome Measures

Primary Outcomes (1)

  • Whole blood aggregometry in response to 4 agonists

    Day 1, 2, 29, and 30

Study Arms (4)

1

NO INTERVENTION

Baseline

2

EXPERIMENTAL

Aspirin (1 day after a single, 625 mg dose)

Drug: Aspirin

3

EXPERIMENTAL

Omacor

Drug: omega-3 acid ethyl esters

4

EXPERIMENTAL

Omacor plus aspirin

Drug: AspirinDrug: omega-3 acid ethyl esters

Interventions

AspirinDRUG

generic aspirin

24
omega-3 acid ethyl estersDRUG

4, 1 g capsules q.d.

Also known as: Omacor, Lovaza
34

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Research/USD

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Interventions

AspirinOmacor

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

US(1)