Trial Condition(s):

Primary Hypertension

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

Bayer Identifier:

14183

ClinicalTrials.gov Identifier:

NCT00882947

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
38
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design