WHO ICTRP trial
A study to learn how well the study treatment asundexian works and how safe it…
EUCTR2022-000758-28-GR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2022-000758-28-GR |
|---|---|
| Public title | A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent stroke or systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke |
| Scientific title | A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and… |
| Primary sponsor | Bayer AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic… |
| Conditions | Prevention of stroke or systemic embolism in atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10049165 Term: Cerebrovascular accident prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA… |
| Interventions | Product Name: Asundexian Product Code: BAY 2433334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Asundexian CAS Number: 2064121-65-7 Current Sponsor code: BAY 2433334 Concentration unit: mg milligram(s) Concentration type… |
| Registration date | Nov 16, 2022 |
| Target size | 18000 |
| Secondary IDs | 19767;2022-000758-28-DK |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: