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NCT00403767 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
14,269
Enrollment target

NCT00403767: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT00403767 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 14,269 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1751% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00403767, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
14,269 participants
Enrollment target

Study Summary

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Primary Outcome

The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

Interventions

  • DRUG Warfarin
  • DRUG Rivaroxaban
  • DRUG Matching placebo for Rivaroxaban arm (Warfarin placebo)
  • DRUG Matching placebo for Warfarin arm (Rivaroxaban placebo)

Trial Details

FieldValue
Enrollment Target 14,269 participants
Start Date 2006-12
Est. Completion 2010-09
Phase Phase 3

What the finished NCT00403767 record still lists

NCT00403767 is an interventional study that assigns participants to a tested intervention. Its 14,269 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1751% higher).

The record links to 0 conditions, and to 4 interventions - of which Warfarin is the first listed.

NCT00403767 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00403767 about?

NCT00403767 is a clinical study titled "An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation". The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular at...

What is the current status of trial NCT00403767?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 14,269 participants. The study started on 2006-12. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00403767?

The interventions under investigation include: Warfarin (DRUG), Rivaroxaban (DRUG), Matching placebo for Rivaroxaban arm (Warfarin placebo) (DRUG), Matching placebo for Warfarin arm (Rivaroxaban placebo) (DRUG).

Who is sponsoring clinical trial NCT00403767?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00403767's enrollment target sits among peer trials

14,269 16th of 2000 higher than 1,985 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00403767, the US trial registry maintained by the National Library of Medicine. NCT00403767 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.