Germany-based Bayer HealthCare and its US development partner Janssen Research & Development, have started two new Phase III trials to assess rivaroxaban in medically ill patients and children at high-risk of blood clots.
The MARINER trial is designed to assess the safety and efficacy of rivaroxaban to reduce the risk of post-hospital discharge symptomatic venous thromboembolism (VTE) in patients hospitalised for acute medical illness.
The EINSTEIN JUNIOR trial will evaluate the efficacy and safety of rivaroxaban for the treatment and secondary prevention of VTE in children.
Bayer HealthCare member of the executive committee and head of global development Joerg Moeller said: “We have already completed an extensive clinical study programme with more than 10,000 patients to demonstrate the clinical benefits of rivaroxaban in the treatment and secondary prevention of deep vein thrombosis and pulmonary embolism, but we still see significant unmet needs in the area of venous thrombosis, which we want to address through these additional studies.”
The company said that patients who have been hospitalised for treatment of acute medical illnesses are at high-risk of developing VTE during their hospital stay and immediately after discharge, with thromboprophylaxis being a therapeutic approach to reduce the risk of VTE events in these patients.
The MARINER trial will evaluate rivaroxaban 10mg once daily compared with placebo in around 8,000 patients in more than 15 countries for up to 45 days following hospital discharge, while the EINSTEIN JUNIOR trial will assess rivaroxaban according to an age and body weight-adjusted dosing schedule in 150 patients in 20 countries.
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A new oral anticoagulant, rivaroxaban is marketed under the brand name Xarelto and is approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant.
Discovered by Bayer HealthCare, rivaroxaban is being jointly developed with Janssen Research & Development.
Outside the US, Xarelto is marketed by Bayer HealthCare and in the US by Janssen Pharmaceuticals, a Johnson & Johnson Company.
Image: Xarelto is approved in more than 125 countries. Photo: courtesy of freedigitalphotos.net.