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Enrollment for post-market study of riociguat begun
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Bayer announced first patient has been enrolled in a global study of riociguat in individuals with pulmonary arterial hypertension.
Researchers for the phase 4 REPLACE study of riociguat (Adempas) plan to enroll 218 patients who were treated with a phosphodiesterase-5 inhibitor, either as monotherapy or in combination with an endothelin receptor antagonist, who did not reach their therapeutic goal, according to a press release from the company.
The primary endpoint will be a composite of the absence of clinical worsening and improvement in two out of the three of the following: 6-minute walk distance, WHO functional class and N-terminal pro-brain natriuretic peptide level.
“Bayer is committed to improving the lives of patients living with pulmonary arterial hypertension through ongoing research that address important clinical questions on how to manage the disease,” Aleksandra Vlajnic, MD, vice president of medical affairs at Bayer, said in the release. “This study will help improve our understanding of therapeutic choices and how they may impact these patients.”
Disclosure: Vlajnic is an employee of Bayer.