Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01431690 · ClinicalTrials.gov registry record · Phase 1
Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals
A Phase 1 study of Hypertriglyceridemia, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01431690: Completed Phase 1 study of Hypertriglyceridemia, sponsored by AstraZeneca.
NCT01431690 is a Phase 1 study of Hypertriglyceridemia that has completed, run by AstraZeneca. The registered enrollment target is 52 participants, below the 174-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431690, a Phase 1 study of Hypertriglyceridemia, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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®.
Conditions Studied
Interventions
- DRUG warfarin
- DRUG omefas
- DRUG omega-3-acid ethyl esters
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01431690 record still lists
NCT01431690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 174-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Hypertriglyceridemia appearing as the primary indexed condition, and to 3 interventions - of which warfarin is the first listed.
NCT01431690 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01431690 about?
NCT01431690 is a clinical study titled "Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals". 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 mi...
What is the current status of trial NCT01431690?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-08. Estimated completion is 2011-10.
What conditions does trial NCT01431690 study?
This clinical trial studies the following conditions: Hypertriglyceridemia.
What interventions are being tested in trial NCT01431690?
The interventions under investigation include: warfarin (DRUG), omefas (DRUG), omega-3-acid ethyl esters (DRUG).
Who is sponsoring clinical trial NCT01431690?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01431690 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertriglyceridemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01431690's enrollment target sits among peer trials
52 12th of 25 higher than 13 of 25 other Hypertriglyceridemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertriglyceridemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
ACTIVE NOT RECRUITING · Phase 1
-
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
COMPLETED · Phase 1
-
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
COMPLETED · Phase 1
-
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
COMPLETED · Phase 1
-
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
COMPLETED · Phase 1
-
Study of Gemcabene in Adults With FPLD
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia