Trials / Terminated
TerminatedNCT01505881
Follow on Study From RE-ALIGN
Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabigatran etexilate low dose | active treatment (low) |
| DRUG | warfarin 5mg | comparator warfarin |
| DRUG | dabigatran etexilate intermediate dose | active treatment (medium) |
| DRUG | warfarin 1mg | comparator warfarin |
| DRUG | dabigatran etexilate high dose | active treatment (high) |
| DRUG | warfarin 3mg | comparator warfarin |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-01-09
- Last updated
- 2014-07-11
- Results posted
- 2014-07-11
Locations
30 sites across 9 countries: Belgium, Canada, Czechia, Denmark, France, Germany, Netherlands, Norway, Poland
Source: ClinicalTrials.gov record NCT01505881. Inclusion in this directory is not an endorsement.