Clinical trial
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha
Study Start Date: May 2014
Actual Primary Completion Date: August 2015
Actual Study Completion Date: August 2015
Arms:
- Experimental: Andexanet
- Placebo Comparator: Placebo
Category | Value |
---|---|
Study type(s) | Interventional |
Actual enrolment | 80 |
Study start date | 01 May 2014 |
Actual primary completion date | 01 August 2018 |