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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062282
• Other study ID #: 14184
• Secondary ID: VENISVE0610KR
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: April 1, 2011
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: April 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable is 6-minute walking distance		At baseline and month 1,3,6 for an observational period of 6 months	Yes
Secondary	New York Heart Association functional class		Baseline, month 1,3,6	No
Secondary	PH-related symptoms and change of concomitant medication		Baseline, month 1,3,6	No
Secondary	Hemodynamic parameters		If applicable ( at any time during Ventavis treatment)	No
Secondary	Adverse Event collection		If applicable (during the study period)	Yes

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