Table 1.

Main exclusion criteria applicable to both studies

Criteria
Applicable to all individuals
History of medical disorders or conditions that could impair an individual’s ability to participate in or complete the study
Febrile illness in the week before the study
History of severe allergies and nonallergic drug reactions
Pathological changes in the electrocardiogram, such as a second- or third-degree atrioventricular block, prolongation of the QRS complex to more than 120 ms, or prolongation of the QTc interval to more than 450 ms
Participation in another clinical study in the previous 3 months
Donation of more than 100 mL blood in the preceding 4 weeks or 500 mL in the preceding 3 months
Pregnant women and women of childbearing age not using double-barrier contraception
Applicable to patients with renal impairment
Concurrent diagnosis of severe cerebrovascular or cardiac disorders, acute renal failure, acute nephritis, or failure of any organ system other than the kidney
Diagnosis of malignancy within the previous 5 years
Severe infection or any clinically significant illness in the 4 weeks before drug administration
Any organ transplant
Percutaneous transluminal coronary angioplasty or coronary artery bypass graft <6 months before riociguat administration
Concomitant thrombotic disorders
Platelet count less than 100 × 109/L
Diabetes mellitus with a fasting blood glucose level of >220 mg/dL or glycosylated hemoglobin levels of >10%
History of bleeding in the past 3 months
Concomitant use of potent CYP3A4 inhibitors, phosphodiesterase-5 inhibitors, endothelin receptor antagonists, prostacyclins, or treatment with any medication (except those necessary for the treatment of kidney disease or related complications)
Change in chronic medication less than 4 weeks before dosing