Follow on Study From RE-ALIGN

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Warfarin

Criteria

Inclusion criteria:

1. Completed study 1160.113 per protocol

2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension

2. severe renal impairment

3. active liver disease

4. increased risk of bleeding