At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 46 enrolled
Drug / intervention
BI 655075 +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BI 655075 and Placebo for Hemorrhage. Completed, enrolled 46 participants across 1 site.
Detailed Summary
To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionMay 2014
Study CompletionAug 2014
TodayJul 2026
First PostedOct 7, 2013
Enrollment StartSep 1, 2013
Primary CompletionMay 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.7 years ago
Interventions
BI 655075drug
BI 655075drug
Placebodrug
BI 655075drug
Placebodrug
Placebodrug
Placebodrug
BI 655075drug