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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01062282 |
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Date of registration:
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20/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
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Scientific title:
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VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01062282 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: Iloprost (Ventavis BAYQ6256)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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PH-related symptoms and change of concomitant medication
[Time Frame: Baseline, month 1,3,6]
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Hemodynamic parameters
[Time Frame: If applicable ( at any time during Ventavis treatment)]
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New York Heart Association functional class
[Time Frame: Baseline, month 1,3,6]
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Adverse Event collection
[Time Frame: If applicable (during the study period)]
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Secondary ID(s)
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14184
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VENIS
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VE0610KR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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