CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
Apixaban +3 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.

Search/NCT02074358
NCT02074358Phase 1Completed
CompareCT.gov

A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects

Bristol-Myers Squibb·interventional·Posted Feb 28, 2014·Updated Aug 13, 2015

In Brief

A Phase 1 clinical trial evaluating Apixaban, Cofact (4-Factor PCC), and 2 other interventions for Anticoagulation. Completed, enrolled 43 participants.

Detailed Summary

The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnticoagulation
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2014
Enrollment StartFeb 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.3 years ago

Interventions

Apixabandrug

Cofact (4-Factor PCC)drug

Beriplex P/N (4-Factor PCC)drug

Placebo (Saline solution)drug