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OpenTrials
Completed

NCT Number: NCT01062282

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

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

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Iloprost (Ventavis BAYQ6256)

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 4, 2010
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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