Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891850
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2016-08-26
Brief Title:
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPLACE
Brief Summary:
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors PDE-5i therapy in pulmonary arterial hypertension PAH patients
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001067-36 | EUDRACT_NUMBER | None | None |