Status:
TERMINATED
Dabigatran Etexilate in Patients With Mechanical Heart Valves
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged 18-75
- Patients who have received a bileaflet mechanical heart valve
- Exclusion criteria:
- Prior valve surgery
- Uncontrolled hypertension
- severe renal impairment
- active liver disease
- increased risk of bleeding
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT01452347
Start Date
October 1 2011
End Date
June 1 2013
Last Update
August 6 2014
Active Locations (40)
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1
1160.113.32003 Boehringer Ingelheim Investigational Site
Brussels, Belgium
2
1160.113.32007 Boehringer Ingelheim Investigational Site
Brussels, Belgium
3
1160.113.32002 Boehringer Ingelheim Investigational Site
Genk, Belgium
4
1160.113.32005 Boehringer Ingelheim Investigational Site
Ghent, Belgium