Subjects with PH due to • Pulmonary arterial hypertension (PAH) [Venice protocol] or • Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: BAY 63-2521
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive n
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male and female patients with PH of WHO functional class II or III due to PAH or CTEPH with mean pulmonary vascular resistance >300 dyn*sec*cm 5 and mean pulmonary artery pressure >25 mmHg; In case of CTEPH, the diagnosis must have been established by 2 of the 4 following imaging methods: perfusion-ventilation scan, spiral CT, MR angiogram, pulmonary angiogram; and patients must be either inoperable, refuse to be operated, or do not have an obligatory indication for an acute operation. Right-heart catheterization for measurement of hemodynamic parameters for the definite diagnosis of PH (see Section 4.6.1) must have been performed independently of this study. Right-heart catheterization results must not be older than 4 weeks at study start; 18 to 75 years of age; Normal body weight: BMI between 18 and 35 kg/m2; Women without childbearing potential will be included in the study (postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, women with hysterectomy); Women of childbearing potential will be included in the study only if the pregnancy test is negative and a combination of condoms with a further safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs) is granted; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participation in another clinical trial during the preceding 3 months; Chronic treatment with specific medication for pulmonary hypertension, e.g. prostacyclins, PDE 5 inhibitors Donation of more than 100 mL of blood in the preceding 4 weeks; Blood donation of approximately 500 mL in the preceding 3 months; Anemia with a hemoglobin level below 10.0 mg/dl; Relevant pulmonary diseases including • Parasitic diseases affecting the lungs, • Bronchial asthma, • Congenital abnormalities of the lungs, thorax, and diaphragm, • Pulmonary artery or pulmonary valve stenosis (documented by corresponding pressure gradients detected by right-heart catheterization), • Pulmonary venous hypertension with pulmonary capillary wedge pressure >15 mmHg; Relevant diseases influencing systemic hemodynamics including • Acute or chronic left heart failure, • Severe (systemic) arterial hypertension [SBP >200 mmHg or diastolic blood pressure (DBP) >120 mmHg], • Congenital or acquired valvular or myocardial disease; especially coronary artery disease and dilatative cardiomyopathy; Relevant disorders in blood gases including • Arterial oxygen pressure (PaO2) 55 mmHg; Coagulation disorders including • Deficiencies in blood coagulation [based on relevant changes in coagulation parameters such as bleeding time, thrombin time, prothrombin time, partial thromboplastin time (PTT)] due to inherited or acquired blood coagulation disorders such as defects in factor VIII (eg hemophilia A/B, von Willebrand's disease), factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, deficient coagulation due to auto-antibodies against coagulation factors such as in lupus erythematosus, anticoagulant treatment, • Disseminated intravascular coagulation, • Deficient thrombocyte function or platelets 2.5 mg/dL / 43 ?mol/L), • Renal insufficiency (creatinine >2 mg/dL / 177 ?mol/L) or proteinuria >1 g/day); Other relevant medical disorders including • Primary or secondary immunodeficiencies; • Previous therapeutic radiation of lungs or mediastinum; • Esophageal varices > grade I in case of porto-pulmonary hypertension; • Intracranial pressure >20 mmHg; • Sickle cell anemia; • Pregnant or breast-feeding women or women of childbearing potential not using a combination of condoms and a further safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs). Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor; Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies; Patients with hypersensitivity to the investigational drug or inactive constituents; Resting heart rate in the awake patient 105 BPM; Systolic blood pressure <100 mmHg; Relevant pathological changes in the ECG such as a second or third-degree AV block, pro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety, tolerability, and feasibility of individual titration of BAY 63 2521 according to peripheral systolic blood pressure. In addition, long term safety and tolerability of BAY 63 2521 should be investigated during the Optional Open Label Extension Period ;Secondary Objective: Secondary objectives of the study are to assess the pharmacodynamics and pharmacokinetics of BAY 63 2521.;Primary end point(s): None | — |
Countries
Germany
Contacts
Public ContactBayer Clin. Trials Contact CTP Team
Bayer HealthCare AG
Outcome results
None listed