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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).

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
Portola Pharmaceuticals

13 total trials

What the finished NCT01583218 record still lists

NCT01583218 is an interventional study that assigns participants to a tested intervention. Its 7,513 participants enrollment target places it among the larger protocols in the corpus, below the 12,934-participant average among 3 other Venous Thromboembolism (VTE) trials with a reported enrollment target (42% lower).

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 names 20 study sites across 5 states, led by 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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Related registry views

Source: ClinicalTrials.gov NCT01583218, the US trial registry maintained by the National Library of Medicine. NCT01583218 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.