Clinical trial • Phase III • Cardiology

milvexian for Atherothrombotic and thromboembolic disorders

Phase III trial of milvexian for Atherothrombotic and thromboembolic disorders. 56 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atherothrombotic and thromboembolic disorders
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
20-12-2023
First CTIS Authorization Date
12-02-2024

Trial design

Phase III trial across 1 site in Belgium.

Target Sample Size
56

Recruitment

Planned Sample Size
56
Recruitment Window Months
15

Geography

Total Number Of Sites
1
Total Number Of Participants
56

Belgium

Earliest CTIS Part Ii Submission Date
26-01-2024
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
426
Number Of Sites
1
Number Of Participants
56

Sites

Site Name
Janssen Pharmaceutica
Department Name
Janssen Clinical Pharmacology Unit
Contact Person Name
Samiha Takhtoukh
Contact Person Email
stakhtou@its.jnj.com
Number Of Participants
56

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
milvexian
Active Substance
milvexian
Routes Of Administration
Oral (tablet)
Route
Oral

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