Bristol-Myers Squibb and Pfizer Initiate New Study in the Apixaban Phase 3 Clinical Trial Program
News Jun 12, 2008
Bristol-Myers Squibb Company and Pfizer have announced the start of a new Phase 3 clinical trial to assess the effect of apixaban in patients with venous thromboembolism (VTE), a potentially fatal disease process that begins with blood clots in the leg veins or lungs.
Apixaban, which is currently being developed by the two companies, is an investigational oral, highly selective factor Xa inhibitor, a new class of agents with therapeutic potential to prevent and treat blood clots.
The AMPLIFY (Apixaban after the initial Management of Pulmonary embolism and deep vein thrombosis with First-line therapy) trials are part of the EXPANSE program - the global Phase 3 clinical development trial program for apixaban.
AMPLIFY and AMPLIFY-EXT are two major clinical trials involving approximately 7,300 patients with deep vein thrombosis (DVT), a blood clot in the vein, or pulmonary embolism (PE), a potentially fatal condition caused by a blood clot blocking a vessel in the lung.
“The initiation of this apixaban Phase 3 trial represents Bristol-Myers Squibb’s and Pfizer’s commitment to furthering research in the treatment of VTE, a serious disease that affects 1.3 million people annually in the US and Europe,” said Jack Lawrence, Vice President, Research and Development, Bristol-Myers Squibb.
“Current oral drug treatment options for the treatment of patients with VTE are primarily vitamin K antagonists (VKA), such as warfarin. Limitations of VKAs include a slow onset of action, a narrow therapeutic window necessitating regular coagulation monitoring and dose adjustment, and multiple food and drug interactions.”
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