Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Riociguat; Sildenafil Citrate

Criteria

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