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| ID | Type | Description | Link |
|---|---|---|---|
| 300341 |
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The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventavis (Iloprost, BAYQ6256) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange | ||
| Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical tolerability of the long-term use of iloprost aerosol | ||
| Serious Adverse Events and deaths | ||
| Effect of long-term administration of inhaled iloprost on mortality and transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20153158 | Derived | Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11. |
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| Exercise capacity |
| Acute effect of inhaled iloprost on hemodynamics and gas exchange |
| Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange |
| Quality of Life |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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