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

April 16, 2009 updated by: Bayer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Many Locations, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Ventavis (Iloprost, BAYQ6256)
Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events
Time Frame: At week 4,12 and 24
At week 4,12 and 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14183
  • VE0611CN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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