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NCT01431690
An Open-label, 2-cohort Study to Evaluate the Effect of Multiple Doses of Epanova® on the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple-dose Administrations of Epanova® Compared to Lovaza® in Healthy Normal Subjects
Phase 1 trial testing warfarin in Hypertriglyceridemia in 52 participants. Completed in 1 October 2011.
1 October 2011
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 August 2011 |
| Primary completion | 1 October 2011 |
| Estimated completion | 1 October 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- warfarin (warfarin) — full drug profile →
- omefas — full drug profile →
- omega-3-acid ethyl esters — full drug profile →
Conditions studied
- Hypertriglyceridemia — all drugs for Hypertriglyceridemia →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 55, any sex, with Hypertriglyceridemia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetics of R- and S- warfarin
Time frame: 168 hours
The primary endpoints of this study will be the area under the curve (AUC)0-t, AUC0-inf, and maximum concentration (Cmax) of R- and S warfarin and the maximum International Normalized Ratio (INRmax) over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®. -
Pharmacodynamics of R- and S- warfarin
Time frame: 168 hours
The INRmax over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
Sponsor's own description
The primary objective of this study is to determine the effect of Epanova® on the pharmacokinetic and anticoagulant activity of warfarin. The secondary objective of this study is to compare the systemic exposure of EPA and DHA following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are likely to be administered to patients with cardiovascular disease who are recommended to consume low-fat meals.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
No Effect of Omega-3 Carboxylic Acids on Pharmacokinetics/Pharmacodynamics of Warfarin or on Platelet Function When Co-administered with Acetylsalicylic Acid: Results of Two Phase I Studies in Healthy Volunteers.
Offman E, Davidson M, Nilsson C. · · 2017 · cited 1× · PMID 28197979 · DOI 10.1007/s40256-017-0217-4
Verify or expand the search:
- PubMed search for NCT01431690
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Hypertriglyceridemia
Currently open trials in the same condition.
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Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01431690 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 23 April 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01431690.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing