Trial Condition(s):
Hypertension, Pulmonary
Interaction study in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg TID
Bayer Identifier:
11917
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients with pulmonary hypertension stable for the last 6 weeks - Treated with Sildenafil 3 × 20 mg - Undergoing routine invasive diagnostics.
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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 |
Trial Design
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
Primary Outcome
- Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.Timeframe: At baseline, throughout study days 1 and 2
Additional Information
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