Status:
TERMINATED
Follow on Study From RE-ALIGN
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Thromboembolism
Heart Valve Prosthesis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Completed study 1160.113 per protocol
- Continuing need for anticoagulation
- Exclusion criteria:
- uncontrolled hypertension
- severe renal impairment
- active liver disease
- increased risk of bleeding
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01505881
Start Date
December 1 2011
End Date
June 1 2013
Last Update
July 11 2014
Active Locations (30)
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1
1160.138.32003 Boehringer Ingelheim Investigational Site
Brussels, Belgium
2
1160.138.32002 Boehringer Ingelheim Investigational Site
Genk, Belgium
3
1160.138.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
4
1160.138.11001 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada