Clinical trial
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075…
NCT01955720 · Boehringer Ingelheim, Industry · Completed
Key facts
| NCT number | NCT01955720 |
|---|---|
| Title | Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran |
| Official title | Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers |
| Lead sponsor | Boehringer Ingelheim, Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Hemorrhage |
| Intervention type | Drug |
| Interventions | BI 655075, Placebo |
| Enrollment | 46 |
| Start date | Sep 1, 2013 |
| Primary completion | May 1, 2014 |
| Completion | Aug 1, 2014 |
| First posted | Oct 7, 2013 |
| Last update posted | Feb 11, 2016 |
| Countries | Belgium |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: