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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01062282
First received: August 20, 2009
Last updated: April 1, 2011
Last verified: April 2011
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • New York Heart Association functional class [ Time Frame: Baseline, month 1,3,6 ] [ Designated as safety issue: No ]
  • PH-related symptoms and change of concomitant medication [ Time Frame: Baseline, month 1,3,6 ] [ Designated as safety issue: No ]
  • Hemodynamic parameters [ Time Frame: If applicable ( at any time during Ventavis treatment) ] [ Designated as safety issue: No ]
  • Adverse Event collection [ Time Frame: If applicable (during the study period) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Medical Director, Bayer Korea LTD
ClinicalTrials.gov Identifier: NCT01062282     History of Changes
Other Study ID Numbers: 14184, VENIS, VE0610KR
Study First Received: August 20, 2009
Last Updated: April 1, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014