Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02825160
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2016-06-15
Brief Title:
Non-interventional Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension PAH
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH
Detailed Description:
This local prospective non-interventional company sponsored multi-center single-cohort study includes patients treated with Ventavis for PAH A total of 270 patients valid for safety analysis is planned to be enrolled in 5 years Target population is patients with PAH diagnosis This study is performed as an all-patient investigation therefore all patients who receive Ventavis treatment for PAH need to be registered The treatment should be performed based on the product label in Japan The standard observation period will last for 12 months from starting Ventavis treatment In addition the extension observation will be carried out as long as Ventavis treatment continues or at most for more 4 years The standard observation points are 3 month and
1 to 5 years
1 to 5 years
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