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

Completed

• Conditions: Primary Hypertension
• Interventions: Drug: Ventavis (Iloprost, BAYQ6256)

• Registration Number: NCT00882947
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Last Update Submitted: 2009-04-16
• Study First Posted: 2009-04-17
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Ventavis (Iloprost, BAYQ6256)	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	At week 4,12 and 24

Secondary Outcome Measures

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