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

Bayer

Status and phase: Completed; Phase 1

Conditions: Hypertension, Pulmonary

Treatments: Drug: Riociguat (Adempas, BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680654

2008-000914-65 (EudraCT Number)

11917

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)