Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rivaroxaban once daily 8 days · 1 trial · 2 indications
Rivaroxaban plasma concentrations was assessed by the reference method at the different sampling points to determine the area under the curve (AUC)
Cmax of rivaroxaban was assessed
Tmax of rivaroxaban was assessed
| Arm | Type | Description |
|---|---|---|
| morbidly obese patients with BMI ≥ 40 | EXPERIMENTAL | Morbidly obese patients with BMI ≥ 40 |
| Patients operated by gastric bypass | EXPERIMENTAL | Patients operated by gastric bypass for over a year and with stable weight |
| Patients operated by sleeve gastrectomy | EXPERIMENTAL | Patients operated by sleeve gastrectomy for over a year and with stable weight |
| Control group: non-operated subjects | EXPERIMENTAL | Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups. |
| Name | Type | Description |
|---|---|---|
| rivaroxaban 20 mg once daily 8 days | DRUG | Blood samples for the measurement of rivaroxaban PK parameters |
Inclusion Criteria: * Creatinine clearance measured by the Cockroft formula ≥ 60 mL / min * Patient meeting the specific criteria of one of the 4 groups: * morbidly obese patients with BMI ≥ 40 * Patients operated by gastric bypass for over a year and with stable weight * Patients operated by sleev...
Rivaroxaban once daily 8 days is an investigational small molecule being studied for use in patients undergoing bariatric surgery, specifically to evaluate its pharmacokinetics in individuals with morbid obesity. It is currently in Phase 1 clinical development and is not yet approved for this indication.
Rivaroxaban once daily 8 days is a small molecule that targets Factor Xa, an enzyme involved in blood coagulation. By inhibiting Factor Xa, it reduces thrombin generation and helps prevent blood clot formation. This mechanism is being studied in the context of bariatric surgery to understand how the drug behaves in this patient population.
Rivaroxaban once daily 8 days is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical research to evaluate this drug in patients undergoing bariatric surgery.
Rivaroxaban once daily 8 days is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities for any use. The ongoing research is focused on evaluating its pharmacokinetics in patients with morbid obesity who are undergoing bariatric surgery.
Rivaroxaban once daily 8 days is being studied in a completed Phase 1 clinical trial with the identifier NCT04180436, titled 'Pharmacokinetics of Rivaroxaban After Bariatric Surgery.' This trial enrolled 67 participants in France and included healthy volunteers aged 18 years and older, with no randomization or blinding.