Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 308120 | Other Identifier | Company internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ventavis, BAYQ6256) | Drug | The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. | Month 3 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. | all scheduled visits (Study period is min. 2 years and max. 4 years) | |
| Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest | F-29609 | France | ||||
Not provided
Not provided
Not provided
Not provided
| all scheduled visits (Study period is min. 2 years and max. 4 years) |
| Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. | all scheduled visits (Study period is min. 2 years and max. 4 years) |
| The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. | all scheduled visits (Study period is min. 2 years and max. 4 years) |
| Other safety variable | Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation | At all scheduled visits (Study period is min. 2 years and max. 4 years) |
| Other safety variables (optional assessment) | Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses | At all scheduled visits (Study period is min. 2 years and max. 4 years) |
| Clamart |
| 92141 |
| France |
| Lille | 59037 | France |
| Lyon | 69394 | France |
| Pessac | 33604 | France |
| Reims | 51092 | France |
| Strasbourg | 67091 | France |
| Vandœuvre-lès-Nancy | 54500 | France |
| Donaueschingen | Baden-Wurttemberg | 78166 | Germany |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Löwenstein | Baden-Wurttemberg | 74245 | Germany |
| Erlangen | Bavaria | 91054 | Germany |
| München | Bavaria | 80336 | Germany |
| München | Bavaria | 81377 | Germany |
| Regensburg | Bavaria | 93053 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Cologne | North Rhine-Westphalia | 50924 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Mönchengladbach | North Rhine-Westphalia | 41069 | Germany |
| Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| Homburg/Saar | Saarland | 66421 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Berlin | State of Berlin | 13353 | Germany |
| Erfurt | Thuringia | 99089 | Germany |
| Bologna | 40138 | Italy |
| Pavia | 27100 | Italy |
| Pisa | 56100 | Italy |
| Roma | 00161 | Italy |
| Coimbra | Coimbra District | 3000-075 | Portugal |
| Lisbon | 1150-291 | Portugal |
| Barcelona | Barcelona | 08036 | Spain |
| Córdoba | Córdoba | 14004 | Spain |
| Barcelona | 08035 | Spain |
| Madrid | 28041 | Spain |
| Glasgow | G11 6NT | United Kingdom |
| London | NW3 2PF | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided