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NCT00362232 · ClinicalTrials.gov registry record · Phase 3

Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

A Phase 3 study of Venous Thromboembolism, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
3,148
Enrollment target
20
Study locations

NCT00362232 is a Phase 3 study of Venous Thromboembolism that has completed, run by Bayer. The registered enrollment target is 3,148 participants, below the 6,229-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT00362232, a Phase 3 study of Venous Thromboembolism, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
3,148 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Conditions Studied

Venous Thromboembolism

Interventions

  • DRUG Enoxaparin
  • DRUG Rivaroxaban (Xarelto, BAY59-7939)
  • DRUG Placebo: tablet of Rivaroxaban
  • DRUG Placebo: syringes of Enoxaparin

Study Locations (20)

Florida

  • - Boynton Beach
  • - Clearwater
  • - DeLand
  • - Hollywood
  • - Jacksonville
  • - Pensacola
  • - Pinellas Park

California

  • - Bakersfield
  • - Encinitas
  • - Fountain Valley
  • - La Jolla
  • - Torrance
  • - Yuba City

Colorado

  • - Centennial
  • - Denver
  • - Englewood

Alabama

  • - Birmingham
  • - Tuscaloosa

Arizona

  • - Phoenix

Arkansas

  • - Little Rock

Trial Details

FieldValue
Enrollment Target 3,148 participants
Start Date 2006-06
Est. Completion 2008-01
Phase Phase 3

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00362232

The ClinicalTrials.gov registry entry for NCT00362232 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,229-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (49% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 4 interventions - of which Enoxaparin is the first listed.

NCT00362232 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00362232 about?

NCT00362232 is a clinical study titled "Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.". The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

What is the current status of trial NCT00362232?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,148 participants. The study started on 2006-06. Estimated completion is 2008-01.

What conditions does trial NCT00362232 study?

This clinical trial studies the following conditions: Venous Thromboembolism.

What interventions are being tested in trial NCT00362232?

The interventions under investigation include: Enoxaparin (DRUG), Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Placebo: tablet of Rivaroxaban (DRUG), Placebo: syringes of Enoxaparin (DRUG).

Who is sponsoring clinical trial NCT00362232?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00362232 being conducted?

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