Trial Condition(s):
Interaction study in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg TID
11917
Not Available
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.
- Patients with pulmonary hypertension stable for the last 6 weeks - Treated with Sildenafil 3 × 20 mg - Undergoing routine invasive diagnostics.
- Pre-existing lung disease other than pulmonary arterial hypertension, - Acute or severe chronic left heart failure, - Severe coronary artery disease, - Uncontrolled arterial hypertension; - Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension, - Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg, - PaCO2 > 55 mmHg, - Severe hepatic insufficiency, - Severe renal insufficiency, - Administration of strong CYP3A4 inhibitors or inductors
Locations | Status | |
---|---|---|
Locations Investigative Site Gießen, Germany, 35392 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Löwenstein, Germany, 74245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Interaction study to investigate safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics of single doses of 0.5 and 1 mg of BAY 63-2521 in patients with PAH and stable treatment of sildenafil 20 mg TID in a non-randomized, non-blinded design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1