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

  • STATUS
    Not Recruiting
  • participants needed
    218
  • sponsor
    Bayer
Updated on 20 August 2022
hypertension
heart disease
diuretics
connective tissue disease
sildenafil
tadalafil
right heart catheterization
left ventricular end-diastolic pressure

Summary

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

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.

Details
Condition Pulmonary Arterial Hypertension
Treatment Tadalafil, Sildenafil, Adempas (Riociguat, BAY63-2521)
Clinical Study IdentifierNCT02891850
SponsorBayer
Last Modified on20 August 2022

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