Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02428985
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2015-04-21
Brief Title:
Prospective Non-interventional Multi-center Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension PAH
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2024-01
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:
JPMS-PAH
Brief Summary:
The primary objective in this study is to collect post-marketing information on Riociguat safetyThus the information on adverse events AEs and adverse drug reactions ADRs that occur within the first 12 months and in the following 6 -year observation at most after starting Riociguat treatment under the routine clinical practice will be collected
The secondary objectives are collecting information on Riociguat effectiveness such as 6-Minute Walking Distance 6MWD Test Since it is assumed that Riociguat is for long-term use information on Pulmonary Arterial Hypertension PAH clinical worsening will also be surveyed once a year
The secondary objectives are collecting information on Riociguat effectiveness such as 6-Minute Walking Distance 6MWD Test Since it is assumed that Riociguat is for long-term use information on Pulmonary Arterial Hypertension PAH clinical worsening will also be surveyed once a year
Detailed Description:
This local prospective non-interventional multi-center study includes patients treated with Riociguat for PAH A total of 600 patients valid for safety analysis is planned to be included in 4 years This study is performed as an all-case investigation therefore all patients who receive Riociguat treatment for PAH need to be registered in principle The treatment should be performed based on the product label in Japan The standard observation period will last for 12 months from starting Riociguat treatment Safety and effectiveness will be evaluated at the 3rd and 12th month of treatment In addition the extension observation period will be carried out as long as Riociguat treatment continues or at most for more 6 years The purpose is to collect information on safety and effectiveness such as adverse events and clinical worsening of PAH once a year Combining the standard observation and the extension observation period the patient could be followed for at most 7 years When Riociguat treatment is terminated the observation of the patient ends The investigator should record data for each patient as defined in the protocol using the Electronic Data Capture EDC system The duration of the study is of approximately 8 years from PAH indication approval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| AD1510JP | OTHER | Company Internal | None |