BAY63-2521, POC SD invasive hemodynamics in patient with PH
Primary objective: To investigate the safety, tolerability, pharmacokinetics, impact on pulmonary and systemic hemodynamics, and gas exchange of BAY 63-2521.
Study Part A: Individual dose titration of 3 single doses of BAY 63-2521 solution was performed.
Study Part B: Single dose of BAY 63-2521 solution was tested.
- Subjects 18 - 80 years of age with suspected pulmonary hypertension due to pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, or interstitial lung disease.
- Certain pre-existing lung disease - Certain pre-existing cardiovascular disorders - PaO2/FiO2 <50 mmHg - PaCO2 >55 mmHg - Deficiencies of blood coagulation, inherited or acquired blood coagulation disorders - Disseminated intravascular coagulation - Deficient platelet function, thrombocytopenia - Evidence for major bleeding or intracranial hemorrhage - Latent bleeding risk such as diabetic retinopathy, history of gastrointestinal bleeding, colitis ulcerosa - Severe hepatic insufficiency - Renal insufficiency - Primary or secondary immunodeficiencies - Previous therapeutic radiation of lungs or mediastinum - Concomitant medication not allowed - Elevated intracranial pressure - Women with childbearing potential without reliable contraceptive measures, pregnancy, breast feeding - Subjects whose underlying disease was unlikely to permit them to survive the study - Sickle cell anemia
Gießen, Germany, 35392
E-mail: [email protected]
Phone: Not Available
Proof of concept study to investigate safety, tolerability, pharmacokinetics and the impact on pulmonary-and systemic-hemodynamics and gas exchange of a single-dose of BAY 63-2521 solution in patients with pulmonary hypertension in a non-randomized, non-blinded, dose escalation design.