Janssen R&D announced the addition of three new clinical trials under the EXPLORER global cardiovascular research program for Xarelto (rivaroxaban) to be evaluated for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medial illness.
Janssen and Bayer HealthCare will add the following new trials under the EXPLORER global cardiovascular research program:
- MARINER is a Phase 3 study designed to evaluate the efficacy and safety of rivaroxaban once-daily compared with placebo to reduce the risk of symptomatic DVT and/or PE due to a concurrent medical illness for up to 45 days after hospital discharge. This study will include approximately 8,000 patients in more than 15 countries.
- EINSTEIN JUNIOR, including Phase 1, 2a, 2b and 3 clinical trials, will evaluate rivaroxaban according to an age- and body weight-adjusted dosing schedule for the treatment and secondary prevention of DVT and/or PE in pediatric populations. The study program will include at least 150 patients in 20 countries, and is currently enrolling participants for Phase 2 trials. The Phase 3 study is expected to start in September 2014.
- EINSTEIN CHOICE is a Phase 3 study designed to evaluate whether once-daily rivaroxaban in doses of 10mg or 20mg is superior to aspirin for the prevention of symptomatic recurrent DVT and/or PE in patients who have completed between 6 and 12 months of anticoagulant therapy. The study will include approximately 2,850 patients in 31 countries and is currently enrolling participants.
The EXPLORER global cardiovascular research program now encompasses eight clinical trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease and peripheral artery disease.
In addition, Janssen and Bayer recently entered into an agreement with Portola Pharmaceuticals to initiate Phase 3 studies evaluating Portola’s investigational Factor Xa inhibitor reversal agent, andexanet alfa, for use with Xarelto in emergency situations, such as for patients with major bleeding or those requiring emergency surgery. The clinical collaboration will be in effect through completion of Phase 3 studies with Xarelto and any potential FDA approval of andexanet alfa. Phase 3 studies are expected to start in the first half of 2014.
Xarelto is an oral Factor Xa inhibitor approved to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by heart valve problem, to treat people with PE or DVT, and to reduce the risk or recurrence of DVT or PE following an initial six months of treatment for acute venous thromboembolism.
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