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NCT01486433 · ClinicalTrials.gov registry record · Phase 1

The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

A Phase 1 study of Hypertriglyceridemia, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target
1
Study location

NCT01486433 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.

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The verdict

NCT01486433, 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 is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.

Conditions Studied

Interventions

  • DRUG Simvastatin
  • DRUG omefas
  • DRUG acetylsalicylic acid (ASA)

Study Locations (1)

Arizona

  • - Tempe

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-11
Est. Completion 2012-03
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01486433

The ClinicalTrials.gov registry entry for NCT01486433 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 Simvastatin is the first listed.

NCT01486433 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT01486433 about?

NCT01486433 is a clinical study titled "The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects". The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.

What is the current status of trial NCT01486433?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-11. Estimated completion is 2012-03.

What conditions does trial NCT01486433 study?

This clinical trial studies the following conditions: Hypertriglyceridemia.

What interventions are being tested in trial NCT01486433?

The interventions under investigation include: Simvastatin (DRUG), omefas (DRUG), acetylsalicylic acid (ASA) (DRUG).

Who is sponsoring clinical trial NCT01486433?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01486433 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.