ong-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses
- Conditions
- Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH)MedDRA version: 19.0Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2006-003520-10-DE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
* 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
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) <50 mmHg or fraction of inspired oxygen (FiO2) <50%,
•Arterial partial pressure of carbon dioxide (PaCO2) >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 <40000/?L,
•Evidence for major bleeding or intracranial hemorrhage,
•Latent bleeding risks such as diabetic retinopathy, history of gastrointestinal bleeding (due to gastric or duodenal ulcers), colitis ulcerosa;
Relevant disorders in peripheral organ function including
•Moderate to severe hepatic insufficiency (bilirubin >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 <55 BPM or >105 BPM;
Systolic blood pressure <100 mmHg;
Relevant pathological changes in the ECG such as a second or third-degree AV block, pro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the safety, tolerability, and feasibility of individual titration of BAY 63 2521 according to peripheral systolic blood pressure.<br>In addition, long term safety and tolerability of BAY 63 2521 should be investigated during the Optional Open Label Extension Period<br>;Secondary Objective: Secondary objectives of the study are to assess the pharmacodynamics and pharmacokinetics of BAY 63 2521.;Primary end point(s): None
- Secondary Outcome Measures
Name Time Method