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NCT00643201 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

A Phase 3 study of Venous Thrombosis, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
5,614
Enrollment target
20
Study locations

NCT00643201 is a Phase 3 study of Venous Thrombosis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 5,614 participants, above the 501-participant average among 9 other Venous Thrombosis trials with a reported enrollment target (1021% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT00643201, a Phase 3 study of Venous Thrombosis, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
5,614 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Conditions Studied

Venous Thrombosis

Interventions

  • DRUG Enoxaparin
  • DRUG warfarin
  • DRUG Placebo for apixaban
  • DRUG Placebo for enoxaparin
  • DRUG Placebo for warfarin

Study Locations (20)

California

  • Beaver Medical Group - Banning
  • University Of California San Francisco-Fresno - Fresno
  • University Of California, Davis Medical Center - Sacramento
  • Chest Medicine & Critical Care Medical Gr. Inc. - San Diego
  • Stanford University Medical Center - Stanford
  • Harbor Ucla Medical Center - Torrance

Florida

  • Bay Pines Va Healthcare Systems - Bay Pines
  • Daniel G. Lorch, Jr, Md, Cpi - Brandon
  • Research Alliance, Inc. - Clearwater
  • River City Clinical Research - Jacksonville
  • Pasadena Center For Medical Research - St. Petersburg

Alabama

  • Alabama Clinical Therapeutics, Llc - Birmingham
  • Horizon Research Group, Inc. - Mobile

Arkansas

  • Fort Smith Lung Center - Fort Smith
  • University Of Arkansas For Medical Sciences - Little Rock

Colorado

  • New West Physicians - Golden
  • Drogue Medical, Llc - Wheat Ridge

Connecticut

  • Bridgeport Hospital - Bridgeport
  • Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med - New Haven

District of Columbia

  • George Washington University Medical Faculty Associates - Washington D.C.

Trial Details

FieldValue
Enrollment Target 5,614 participants
Start Date 2008-07
Est. Completion 2013-03
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00643201

The ClinicalTrials.gov registry entry for NCT00643201 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5,614 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 501-participant average among 9 other Venous Thrombosis trials with a reported enrollment target (1021% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Thrombosis appearing as the primary indexed condition, and to 5 interventions - of which Enoxaparin is the first listed.

NCT00643201 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT00643201 about?

NCT00643201 is a clinical study titled "Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism". The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

What is the current status of trial NCT00643201?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,614 participants. The study started on 2008-07. Estimated completion is 2013-03.

What conditions does trial NCT00643201 study?

This clinical trial studies the following conditions: Venous Thrombosis.

What interventions are being tested in trial NCT00643201?

The interventions under investigation include: Enoxaparin (DRUG), warfarin (DRUG), Placebo for apixaban (DRUG), Placebo for enoxaparin (DRUG), Placebo for warfarin (DRUG).

Who is sponsoring clinical trial NCT00643201?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00643201 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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.