Long term open follow-up with H376/95 vs. warfarin

Study identifier:SH-TPA-0004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Long-Term Treatment with the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients with Atrial Fibrillation. A long term follow-Up Study

Medical condition

Stroke prevention in patients with atrial fibrillation

Phase

Phase 2

Healthy volunteers

No

Study drug

EXANTA

Sex

All

Actual Enrollment

220

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Aug 1999
Primary Completion Date: 01 Jun 2004
Study Completion Date: 01 Apr 2006

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria