Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

December 15, 2011 updated by: Astellas Pharma Inc

Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects are eligible for the study if all of the following apply:

  • Subject has paroxysmal permanent or persistent NVAF
  • Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
  • Legal minimum age requirement (country-specific).
  • Written informed consent has been obtained.

Exclusion Criteria:

  • History of heart valve disorders
  • History of rheumatic fever.
  • History of stroke and/or systemic embolism (including TIA).
  • History of Acute Coronary Syndrome (ACS).
  • Indication for warfarin other than NVAF.
  • Known hemorrhagic disorder and/or coagulation disorder.
  • Active bleeding or any condition associated with increased risk of bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low dose
Drug: YM150
Oral
Active Comparator: 4
Drug: warfarin
Oral
Experimental: 2
Middle dose
Drug: YM150
Oral
Experimental: 3
High dose
Drug: YM150
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Time Frame: 16 Weeks
16 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic stroke
Time Frame: 16 Weeks
16 Weeks
Incidence of transient ischemic attack (TIA)
Time Frame: 16 Weeks
16 Weeks
Incidence of systemic thromboembolic event
Time Frame: 16 Weeks
16 Weeks
Incidence of the bleeding rates
Time Frame: 16 Weeks
16 Weeks
Other safety assessments
Time Frame: 16 Weeks
16 Weeks
PK, PD variables
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 15, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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