Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 59-7939 · 1 trial · 5 indications
The primary efficacy outcomes (i.e., recurrent venous thromboembolism \[VTE\] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism \[PE\] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Rivaroxaban 10 mg once daily for 12 months |
| Arm 2 | EXPERIMENTAL | Rivaroxaban 20 mg once daily for 12 months |
| Arm 3 | ACTIVE_COMPARATOR | ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months |
| Name | Type | Description |
|---|---|---|
| BAY 59-7939 | DRUG | 10 mg tablet once daily for 12 months |
| ASA | DRUG | 100 mg tablet once daily for 12 months |
Inclusion Criteria: * Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week Exclusion Criteria: * Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indica...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| ICON Plc | ICLR | 1 | N/A | Undisclosed |
| Penumbra, Inc. | PEN | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | - | Undisclosed |
| AngioDynamics, Inc. | ANGO | 2 | N/A | Undisclosed |
BAY 59-7939 is an investigational small molecule being developed for the treatment of pulmonary embolism, a condition in which a blood clot blocks an artery in the lungs. It is also being studied for related conditions including thromboembolism, thrombosis, venous thrombosis, and venous thromboembolism.
BAY 59-7939 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY.
BAY 59-7939 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and no active trials are currently listed.
BAY 59-7939 has been studied in one completed Phase 3 clinical trial, identified as NCT02064439. This randomized, double-blind, active-controlled study enrolled 3,365 participants and evaluated the drug in the long-term prevention of recurrent symptomatic venous thromboembolism.
BAY 59-7939 is a small molecule that targets the coagulation system to prevent blood clot formation. It is being studied for its ability to reduce the risk of recurrent venous thromboembolism in patients with pulmonary embolism and related thrombotic conditions.