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| ID | Type | Description | Link |
|---|---|---|---|
| VENIS | |||
| VE0610KR |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is 6-minute walking distance | At baseline and month 1,3,6 for an observational period of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association functional class | Baseline, month 1,3,6 | |
| PH-related symptoms and change of concomitant medication | Baseline, month 1,3,6 | |
| Hemodynamic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pulmonary hypertension in Korea
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | South Korea |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| If applicable ( at any time during Ventavis treatment) |
| Adverse Event collection | If applicable (during the study period) |
| D002318 |
| Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |