check_circleStudy Completed

Pulmonary Hypertension

Bayer Identifier:

14184

ClinicalTrials.gov Identifier:

NCT01062282

EudraCT Number:

Not Available

EU CT Number:

Not Available
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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).

Trial summary

Enrollment Goal
41
Trial Dates
July 2006 - June 2009
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • The primary efficacy variable is 6-minute walking distance
    date_rangeTime Frame:
    At baseline and month 1,3,6 for an observational period of 6 months
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    Safety Issue:
    yes

Secondary Outcome

  • New York Heart Association functional class
    date_rangeTime Frame:
    Baseline, month 1,3,6
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    Safety Issue:
    no
  • PH-related symptoms and change of concomitant medication
    date_rangeTime Frame:
    Baseline, month 1,3,6
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    Safety Issue:
    no
  • Hemodynamic parameters
    date_rangeTime Frame:
    If applicable ( at any time during Ventavis treatment)
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    Safety Issue:
    No
  • Adverse Event collection
    date_rangeTime Frame:
    If applicable (during the study period)
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    Safety Issue:
    Yes

Trial design

VENIS - Prospective observational study of Ventavis® inhalation therapy in the treatment of patients with pulmonary arterial hypertension
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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