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

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Iloprost (Ventavis BAYQ6256)

• Registration Number: NCT01062282
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Iloprost (Ventavis BAYQ6256)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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