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A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

NCT00504556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1146

Last updated 2019-02-26

Study results available
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Summary

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Conditions

Interventions

DRUG

Edoxaban (DU-176b)

30mg tablet once daily

DRUG

Edoxaban (DU-176b)

60mg tablet once daily

DRUG

Edoxaban (DU-176b)

30mg tablet two times a day

DRUG

Edoxaban (DU-176b)

60mg tablet two times a day

DRUG

warfarin

warfarin tablets

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • Chile
  • Latvia
  • Mexico
  • Moldova
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504556 on ClinicalTrials.gov