Clinical trial
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Study to Compare the Efficacy, Acceptability, and Safety of Tranexamic Acid Oral Solution 5% With Placebo in the Prevention of Clinically Relevant Bleeding Events in Subjects Treated With Direct Oral Anticoagulants or Vitamin K Antagonists and Undergoing a Single or Multiple Tooth Extraction.
NCT06143787 is registered in ClinicalTrials.gov with Hyloris Developments as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Study to Compare the Efficacy, Acceptability, and Safety of Tranexamic Acid Oral Solution 5% With Placebo in the Prevention of Clinically Relevant Bleeding Events in Subjects Treated With Direct Oral Anticoagulants or Vitamin K Antagonists and Undergoing a Single or Multiple Tooth Extraction.
- Lead sponsor
- Hyloris Developments
- Phase
- Phase 3
- Overall status
- Unknown status
- Start date
- November 7, 2023
- Completion date
- December 27, 2024
- Enrollment
- 280 (estimated)
- Sites
- 19
Conditions
As the registry lists them; a condition with its own page is linked.
bleeding from teeth, bleeding prophylaxis