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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00882947

Enrollment

Registered

2009-04-17

Start date

2006-02-28

Completion date

2008-09-30

Last updated

2009-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension

Keywords

Primary Pulmonary Hypertension (PPH)

Brief 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.

Interventions

DRUGVentavis (Iloprost, BAYQ6256)

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse Events	At week 4,12 and 24

Secondary

Measure	Time frame
6 minute walking test (6-MWT)	At week 4,12 and 24
NYHA functional class	At week 4,12 and 24

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026