Overview

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

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Iloprost
Criteria
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.