Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02007629
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2013-12-06
Brief Title:
Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Open-label International Multicenter Single-arm Uncontrolled Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension PAH Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors PDE-5i
Status:
COMPLETED
Status Verified Date:
2018-12
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:
RESPITE
Brief Summary:
BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors Eg Sildenafil Tadalafil not appropriately responding to therapy will be included Based on previous evidence and on the different modes of action an improvement of exercise capacity heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat
Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months Extended Drug Supply Phase - EDSP under study conditions Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approvalreimbursement eg a long-term extension study compassionate use or named patient program Study termination is also possible at any time
Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months Extended Drug Supply Phase - EDSP under study conditions Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approvalreimbursement eg a long-term extension study compassionate use or named patient program Study termination is also possible at any time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2013-001759-10 | EUDRACT_NUMBER | None | None |