NCT02825160

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 282 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Ventavis (Iloprost, BAYQ6256)	The treatment of Ventavis should comply with the local product information

Timeline

• Start date: 2016-08-01
• Primary completion: 2023-03-31
• Completion: 2023-09-27
• First posted: 2016-07-07
• Last updated: 2024-08-19

Locations

1 site across 1 country: Japan