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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431690
The ClinicalTrials.gov registry entry for NCT01431690 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (70% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.