Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

Bayer

Status: Completed

Conditions: Primary Hypertension

Treatments: Drug: Ventavis (Iloprost, BAYQ6256)

Study type: Observational

Funder types: Industry

Identifiers

NCT00882947

14183

VE0611CN

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both male and female age 18-65 years old
• The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
• Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
• Written informed/data protection consent
• No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.

Exclusion criteria

• Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.

Trial design

38 participants in 1 patient group

Group 1

Treatment:

Drug: Ventavis (Iloprost, BAYQ6256)