About PATENT PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III trial to assess oral riociguat in the treatment of treatment naive patient and pre-treated patients with symptomatic PAH. PATENT is a multi-center, multi-national program with active centers in 32 countries. The program includes a randomized, double-blind, placebo controlled trial phase (PATENT-1) and an open label extension trial phase (PATENT-2).In the PATENT-1 study, 445 patients with symptomatic PAH were randomized to receive either placebo or two different doses of riociguat orally over a period of 12 weeks. The primary endpoint of the trial was improvement in 6-minute walking distance. The riociguat dose was titrated, over a period of eight weeks in doses of 0.5 mg increments from 1.0 mg up to 2.5 mg three times daily. Patients were then followed for an additional four weeks to complete the study. Patients then had the option of participating in the open label extension study, after completing an eight-week blinded sham titration.
Bayer's Investigational Riociguat Granted U.S. FDA Priority Review For Pulmonary Arterial Hypertension And Inoperable Or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
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