Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor
Status:
Completed
Trial end date:
2016-12-29
Target enrollment:
Participant gender:
Summary
BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and
may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary
arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved
the right heart function without unacceptable side effects. Here dose of Riociguat will be
adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary
Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg
Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on
previous evidence and on the different modes of action an improvement of exercise capacity,
heart function and quality of life may be expected if PDE5i treatment is transitioned to
riociguat.
Where Riociguat is pending market approval or reimbursement once the treatment phase is
completed drug can be made available for another 18 months (Extended Drug Supply Phase -
EDSP) under study conditions. Patients may also transition at the end of the maintenance
period or any time during the EDSP to any program that is intended to provide riociguat until
drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named
patient program. Study termination is also possible at any time.