Friday, March 8, 2013

Bayer and JNJ initiate Phase study to evaluate Xarelto (2.5mg twice daily) in patients with CHF and significant CAD

Bayer HealthCare and its cooperation partner Janssen Research & Development, LLC announced today the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto® (rivaroxaban) 2.5 mg twice daily in patients with chronic heart failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for complications following hospitalization for exacerbation of their HF.

Heart failure poses a major public health problem worldwide.1 It is one of the most common reasons for hospitalization in the developed world and places a major burden on hospital staff and resources.2 In the U.S. and Europe, three-quarters of all patients hospitalized with heart failure for the first time will die within five years.3

“COMMANDER-HF will assess whether the addition of low-dose rivaroxaban on top of standard therapy can help reduce the risk of death, heart attack or stroke in this high-risk patient group following hospitalization,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

The U.S. Food and Drug Administration granted a fast track designation process for the COMMANDER-HF study to help facilitate the development process, and expedite the review of rivaroxaban in this indication.
The trial will assess the safety and efficacy of 2.5 mg twice daily rivaroxaban compared to placebo (on a background of standard treatment) in reducing the risk of death, myocardial infarction (MI) or stroke in 5,000 patients with chronic HF and significant CAD following hospitalization. The primary efficacy outcome is the composite of all-cause mortality, MI, or stroke. The principal safety outcome is the composite of fatal bleeding or bleeding into a critical space with a potential for permanent disability.

Xarelto has the broadest indication profile of any of the newer oral anticoagulants. To date, Xarelto is approved for six distinct uses in the venous arterial thromboembolic (VAT) space.












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