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

Bayer

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Drug: Ventavis (Iloprost, BAYQ6256)

Study type: Observational

Funder types: Industry

Identifiers

NCT02825160

17941

Details and patient eligibility

About

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

Full 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.

Enrollment: 282 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

282 participants in 1 patient group

Ventavis

Description:

Ventavis treatment group

Treatment:

Drug: Ventavis (Iloprost, BAYQ6256)