['hypertension, pulmonary']
['riociguat (adempas, bay63-2521)']

        Inclusion Criteria:

          -  Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin
             induced and associated PAH due to congenital heart disease (Group I / Dana Point
             Classification of PH) demonstrating insufficient response to treatment with PDE-5i for
             at least 3 months

          -  Patients with and without endothelin receptor antagonist (ERA) therapy

          -  World Health Organization Functional Class (WHO FC) III at screening

          -  6-minute walking distance (6MWD) of 165-440 m

          -  Cardiac index <3.0 L/min/m*2.

        Exclusion Criteria:

          -  All types of PH except subtypes of Dana Point Group I specified in the inclusion
             criteria

          -  Evidence of clinically significant restrictive or obstructive parenchymal lung
             diseases

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) <30% predicted

          -  History or active state of serious hemoptysis / pulmonary hemorrhage including those
             managed by bronchial artery embolization

          -  Patients unable to perform a valid 6MWD test

          -  Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast
             feeding women, or women with childbearing potential not using a combination of 2
             effective methods of birth control, for example a combination of condoms with a safe
             and highly effective contraception method (prescription oral contraceptives,
             contraceptive injections, contraceptive patch, intrauterine device) or a double
             barrier method is used throughout the study.
      