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You are at:»»Bristol-Myers Squibb Co (NYSE:BMY), Pfizer Inc. (NYSE:PFE) Enroll Patients In Phase IV Trial Of Eliquis
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Bristol-Myers Squibb Co (NYSE:BMY), Pfizer Inc. (NYSE:PFE) Enroll Patients In Phase IV Trial Of Eliquis

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By on BioPharma

Bristol-Myers Squibb Co (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) have announced the first patient has been enrolled into a Phase IV clinical trial called EMANATE designed to assess the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF.

The open-label clinical trial, will assess the effectiveness and safety of Eliquis compared with usual care initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation.

The trial is expected to enroll 1,500 patients from the U.S., Canada, Europe and Asia. Patients will be randomized 1:1 to Eliquis or usual care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within this timeframe. The primary efficacy endpoints are the occurrence of acute stroke, systemic embolism and all-cause death. Primary safety endpoints are major bleeding and clinically relevant non-major bleeding.

“Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with NVAF in a number of countries around the world, including in the U.S., European Union and Japan,” said Steve Romano, senior vice president, head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc. “The initiation of the Phase IV EMANATE study reinforces the long-term commitment of Bristol-Myers Squibb and Pfizer to understanding and improving health in patients with NVAF.”

Shares of BMY are up $0.10, or 0.20%, at $48.90 in pre-market trading with a 52-week range of $41.11 – $57.49. Shares of PFE are inactive in pre-market trading at $30.96 with a 52-week range of $27.76 – $32.96.

 

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