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Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Date:2/11/2013

atients with inoperable CTEPH or with persistent or recurrent CTEPH after PEA were randomized and treated with either riociguat or placebo orally for 16 weeks. The primary endpoint of the trial was improvement in 6-minute walking distance. Riociguat 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 a day. After the titration phase, patients were followed up for another eight weeks on their last dose to complete CHEST-1. Patients from both arms then had the option of participating in the open label extension study (CHEST-2) after completing an eight-week blinded sham titration. CHEST-2 is continuing to investigate riociguat in CTEPH patients.  Results of CHEST-2 will be presented at an upcoming scientific congress in 2013.

About PATENT
PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III trial to assess oral riociguat in the treatment of treatment naïve 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.

About Riociguat
Riociguat (BAY 63-2521), discovered and developed at the Bayer res
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SOURCE Bayer HealthCare
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