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| ID | Type | Description | Link |
|---|---|---|---|
| AC-052-364 |
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The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study. |
|
| 2 | Placebo Comparator | placebo for 6 months followed by an open label period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bosentan | Drug | 65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| exercise capacity | Baseline to end of study | |
| cardiac hemodynamics | Baseline to end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Harbor UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18572079 | Derived | Galie N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8. |
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| placebo | Drug | placebo for 6 months followed by an open-label period |
|
| Torrance |
| California |
| 90509 |
| United States |
| Tufts- New England Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| St. Paul University Hospital | Dallas | Texas | 75390 | United States |
| The Prince Charles Hospital | Brisbane | 4032 | Australia |
| Royal Prince Albert Hospital | Camperdown | Australia |
| St. Vincent's Hospital | Darlinghurst | Australia |
| General Hospital of Vienna | Vienna | 1180 | Austria |
| UZ Gasthuisberg | Leuven | Belgium |
| University of Calgary | Calgary | Alberta | T1Y 6J4 | Canada |
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| Halifax Infirmary | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Victoria Medical Centre | Hamilton | Ontario | L8L 5G4 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Centre de Pneumologie de L'Hospital Laval | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Queen Mary Hospital | Hong Kong | China |
| Interni klinika VFN | Prague | Czechia |
| Marseille-Timone | Marseille | 13005 | France |
| Universitat Greifswald | Greifswald | 17487 | Germany |
| Universitat Greifswald | Greifswald | Germany |
| Universitarsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Medizinische Universitatsklinik | Heidelberg | Germany |
| Universitatsklinikim Leipzig | Leipzig | Germany |
| Klinikum der Universitat Regensburg | Regensburg | Germany |
| Policlinico S. Orsola-Malpighi | Bologna | Italy |
| VU Medisch Centrum | Amsterdam | Netherlands |
| University Hospital Maastricht | Maastricht | Netherlands |
| Hospital Clinic | Barcelona | Spain |
| Hospital Valle d'Hebron | Barcelona | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Zurich University Hospital | Zurich | Switzerland |
| Papworth Hospital | Cambridge | CB3 8RE | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |
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