The apixaban after the initial management of pulmonary embolism and deep vein thrombosis with first-line therapy (Amplify) trials are part of the Expanse program – the global Phase III 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 Amplify-EXT trial has initiated enrollment and will include approximately 2,430 patients who will receive, for an extended 12-month period, apixaban 2.5mg dose or 5mg twice daily compared to patients taking placebo to determine the effects of apixaban on recurrent venous thromboembolism (VTE). Prior to entering the trial, patients will have completed six to 12 months of treatment for DVT or PE.
The Amplify trial is expected to begin in the next few months, and will enroll approximately 4,800 patients with acute DVT or PE and will investigate the safety and efficacy of apixaban 10mg twice daily for one week followed by 5mg twice daily for six months compared to enoxaparin plus warfarin, the two drugs used as the current standard of care.
Jack Lawrence, vice president of R&D at Bristol-Myers Squibb, said: “The initiation of this apixaban Phase III 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.”