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Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy — REPLACE  

Pulmonary Arterial Hypertension Clinical Trial

Official title:
A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal

Clinical Trial Summary

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

Clinical Trial Description

Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i. REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02891850
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 4
Start date January 11, 2017
Completion date March 3, 2020
View Details
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