Trials / Completed
CompletedNCT02104947
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 503 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | idarucizumab | idarucizumab |
Timeline
- Start date
- 2014-05-06
- Primary completion
- 2016-07-25
- Completion
- 2016-10-20
- First posted
- 2014-04-07
- Last updated
- 2018-01-05
- Results posted
- 2017-08-18
Locations
176 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02104947. Inclusion in this directory is not an endorsement.