Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143787
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-11-15
Brief Title:
Effect of TXA Oral Sol 5 in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction
Sponsor:
Hyloris Developments
Organization:
Hyloris Developments
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5 in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction
Detailed Description:
The purpose of this study is 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
A total of approximately 280 subjects will be randomized in two equal treatment groups approximately 140 subjects per group to receive Tranexamic Acid Oral Solution 5 or placebo solution for 7 days Following screening eligible subjects can be randomized within 14 days when all eligibility criteria are confirmed Randomized subjects will undergo tooth extractions and treatment period The treatment period ends at Visit 5 followed by the follow-up period The maximal study duration is about 4 weeks
A total of approximately 280 subjects will be randomized in two equal treatment groups approximately 140 subjects per group to receive Tranexamic Acid Oral Solution 5 or placebo solution for 7 days Following screening eligible subjects can be randomized within 14 days when all eligibility criteria are confirmed Randomized subjects will undergo tooth extractions and treatment period The treatment period ends at Visit 5 followed by the follow-up period The maximal study duration is about 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503719-13-00 | OTHER | EMEA | None |