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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2023-09-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypertension, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ventavis

Ventavis treatment group

Ventavis (Iloprost, BAYQ6256)

Intervention Type DRUG

The treatment of Ventavis should comply with the local product information

Interventions

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Ventavis (Iloprost, BAYQ6256)

The treatment of Ventavis should comply with the local product information

Intervention Type DRUG

Eligibility Criteria

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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.