Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)

  • STATUS
    Recruiting
  • End date
    Sep 27, 2023
  • participants needed
    270
  • sponsor
    Bayer
Updated on 19 September 2022
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 on19 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with PAH
Patients for whom the decision to initiate treatment with Ventavis was made as per investigator's routine treatment practice

Exclusion Criteria

N/A
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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