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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680654

Enrollment

Registered

2008-05-20

Start date

2008-10-31

Completion date

2009-11-30

Last updated

2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary hypertension

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.

Interventions

DRUGRiociguat (Adempas, BAY63-2521)

The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026