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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062282
First Posted: February 4, 2010
Last Update Posted: April 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.

Condition Intervention
Pulmonary Hypertension Drug: Iloprost (Ventavis BAYQ6256)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Biospecimen Retention:   None Retained
n.a

Enrollment: 41
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 20, 2009
First Posted: February 4, 2010
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