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

Phase 1

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Riociguat (Adempas, BAY63-2521)

• Registration Number: NCT00680654
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Study Start: 2008-10
• Primary Completion: 2009-08
• Study Completion: 2009-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Riociguat (Adempas, BAY63-2521)	-

Primary Outcome Measures

Name	Time	Method
Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.	At baseline, throughout study days 1 and 2