Status:
COMPLETED
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients with pulmonary hypertension stable for the last 6 weeks
- Treated with Sildenafil 3 × 20 mg
- Undergoing routine invasive diagnostics.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00680654
Start Date
October 1 2008
End Date
November 1 2009
Last Update
December 16 2015
Active Locations (5)
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1
Heidelberg, Baden-Wurttemberg, Germany, 69126
2
Löwenstein, Baden-Wurttemberg, Germany, 74245
3
Giessen, Hesse, Germany, 35392
4
Greifswald, Mecklenburg-Vorpommern, Germany, 17475