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NCT01583218 · ClinicalTrials.gov registry record · Phase 3

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

A Phase 3 study of Venous Thromboembolism (VTE), sponsored by Portola Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
7,513
Enrollment target
20
Study locations

NCT01583218 is a Phase 3 study of Venous Thromboembolism (VTE) that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 7,513 participants, below the 12,934-participant average among 3 other Venous Thromboembolism (VTE) trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT01583218, a Phase 3 study of Venous Thromboembolism (VTE), has completed, sponsored by Portola Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
7,513 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Conditions Studied

Venous Thromboembolism (VTE)

Interventions

  • DRUG Enoxaparin
  • DRUG Betrixaban

Study Locations (20)

California

  • - Bakersfield
  • - Fresno
  • - La Mesa
  • - Long Beach
  • - Los Angeles
  • - Modesto
  • - San Diego
  • - Stanford
  • - Torrance

Florida

  • - Bay Pines
  • - Clearwater
  • - Jacksonville
  • - Miami
  • - Pensacola
  • - Sarasota
  • - Vero Beach

Georgia

  • - Columbus
  • - Decatur

Alabama

  • - Birmingham

Colorado

  • - Englewood

Trial Details

FieldValue
Enrollment Target 7,513 participants
Start Date 2012-03
Est. Completion 2016-01
Phase Phase 3

Sponsor

Portola Pharmaceuticals

13 total trials

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What the Registry Record Tells You About NCT01583218

The ClinicalTrials.gov registry entry for NCT01583218 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,513 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,934-participant average among 3 other Venous Thromboembolism (VTE) trials with a reported enrollment target (42% lower). The listed sponsor is Portola Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Thromboembolism (VTE) appearing as the primary indexed condition, and to 2 interventions - of which Enoxaparin is the first listed.

NCT01583218 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01583218 about?

NCT01583218 is a clinical study titled "Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)". The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban wil...

What is the current status of trial NCT01583218?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,513 participants. The study started on 2012-03. Estimated completion is 2016-01.

What conditions does trial NCT01583218 study?

This clinical trial studies the following conditions: Venous Thromboembolism (VTE).

What interventions are being tested in trial NCT01583218?

The interventions under investigation include: Enoxaparin (DRUG), Betrixaban (DRUG).

Who is sponsoring clinical trial NCT01583218?

This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01583218 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.