Regado Biosciences permanently halts REGULATE-PCI trial

US-based cardiovascular specialist Regado Biosciences (Nasdaq: RGDO) Regado Biosciences has announced the permanent termination of enrollment in its REGULATE-PCI Phase III trial for its lead program, Revolixys Kit.

The decision was made based on a recommendation from the trial's Data and Safety Monitoring Board (DSMB) following their analysis of the data from the first approximately 3,250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. Last month, the US Food and Drug Administration put a clinical hold on all patient enrolling and dosing of either study drug in the ongoing Phase III REGULATE-PCI trial (The Pharma Letter July 7).

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