Trials / Completed
CompletedNCT04304508
Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,808 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY2433334 | Tablet, taken orally once a day. |
| OTHER | BAY2433334 matching placebo | Tablet, taken orally once a day. |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2022-02-18
- Completion
- 2022-02-18
- First posted
- 2020-03-11
- Last updated
- 2023-04-19
- Results posted
- 2023-04-19
Locations
197 sites across 23 countries: United States, Australia, Austria, Belgium, Bulgaria, China, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04304508. Inclusion in this directory is not an endorsement.