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Bayer's Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Date:4/7/2013

ociguat met their primary endpoint.

About CHEST
CHEST (Chronic Thromboembolic Pulmonary Hypertension sGC-Stimulator Trial) is a Phase III trial to assess the efficacy and safety of oral riociguat in the treatment of patients with either inoperable CTEPH or CTEPH which has persisted or reoccurred after pulmonary endarterectomy (PEA). CHEST is a multi-center, multi-national program with active centers in 26 countries. The program includes a randomized, double-blinded, placebo-controlled trial phase (CHEST-1) and an open label extension trial phase (CHEST-2).

In the CHEST-1 study, 261 patients 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.

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 tria
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SOURCE Bayer HealthCare
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