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| ID | Type | Description | Link |
|---|---|---|---|
| BUILD 2 OL |
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This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bosentan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to all assessed time points in 6-minute walk test distance. | ||
| Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value). | ||
| Transition Dyspnea Index at all assessed time points. | ||
| Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events; serious adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |