Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)

  • STATUS
    Not Recruiting
  • participants needed
    270
  • sponsor
    Bayer
Updated on 15 September 2023
pulmonary arterial hypertension
iloprost
ventavis

Summary

This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

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.

Details
Condition Hypertension, Pulmonary
Treatment Ventavis (Iloprost, BAYQ6256)
Clinical Study IdentifierNCT02825160
SponsorBayer
Last Modified on15 September 2023

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