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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