Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02825160
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
Sponsor:
Bayer
Organization:
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:
False
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?: