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

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ClinicalTrials.gov Identifier: NCT01062282
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : April 4, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Drug: Iloprost (Ventavis BAYQ6256)

Study Design

Study Type : Observational
Actual Enrollment : 41 participants
Time Perspective: Prospective
Official Title: VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension
Study Start Date : July 2006
Primary Completion Date : June 2009
Study Completion Date : June 2009


Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

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

Biospecimen Retention:   None Retained
n.a

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary hypertension in Korea
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062282


Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Medical Director, Bayer Korea LTD
ClinicalTrials.gov Identifier: NCT01062282     History of Changes
Other Study ID Numbers: 14184
VENIS
VE0610KR
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: April 2011

Keywords provided by Bayer:
Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents