Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

April 1, 2011 updated by: Bayer

VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension

The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

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

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pulmonary hypertension in Korea

Description

Inclusion Criteria:

  • The treating physician has chosen Ventavis as a suitable treatment for the patient
  • Patient with PH and classified as NYHA functional class III or IV and WHO group 1

Exclusion Criteria:

  • Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient 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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Iloprost (Ventavis BAYQ6256)
Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy variable is 6-minute walking distance
Time Frame: At baseline and month 1,3,6 for an observational period of 6 months
At baseline and month 1,3,6 for an observational period of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
New York Heart Association functional class
Time Frame: Baseline, month 1,3,6
Baseline, month 1,3,6
PH-related symptoms and change of concomitant medication
Time Frame: Baseline, month 1,3,6
Baseline, month 1,3,6
Hemodynamic parameters
Time Frame: If applicable ( at any time during Ventavis treatment)
If applicable ( at any time during Ventavis treatment)
Adverse Event collection
Time Frame: If applicable (during the study period)
If applicable (during the study period)

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

July 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14184
  • VENIS
  • VE0610KR

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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