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

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.

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Familial Primary Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ventavis (Iloprost, BAYQ6256)

Drug

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Primary outcomes

Frequency of Adverse Events

Time frame: At week 4,12 and 24

Secondary outcomes

6 minute walking test (6-MWT)

Time frame: At week 4,12 and 24
NYHA functional class

Time frame: At week 4,12 and 24

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Apr 17, 2009
Registry last updated: Apr 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed