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This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setipiprant - Dose 1 | Experimental | 100 mg b.i.d. |
|
| Setipiprant - Dose 2 | Experimental | 500 mg b.i.d. |
|
| Setipiprant - Dose 3 | Experimental | 1,000 mg b.i.d |
|
| Matching Placebo | Placebo Comparator | Oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Mangialaio, MD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigative Site # 6204 | Los Angeles | California | 90025 | United States | ||
| Clinical Investigative Site 6208 |
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| Setipiprant | Drug | ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily |
|
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Clinical Investigative Site # 6219 | Tallahassee | Florida | 32308 | United States |
| Clinical Investigative Site 6213 | Normal | Illinois | 61761 | United States |
| Clinical Investigative Site # 6215 | New Orleans | Louisiana | 70112 | United States |
| Clinical Investigative Site # 6211 | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Investigative Site # 6209 | St Louis | Missouri | 63141 | United States |
| Clinical Investigative Site 6205 | The Bronx | New York | 10461 | United States |
| Clinical Investigative Site # 6223 | Winston-Salem | North Carolina | 27157 | United States |
| Clinical Inverstigative Site #6201 | Lake Oswego | Oregon | 97035 | United States |
| Clinical Investigative Site # 6207 | Medford | Oregon | 97504 | United States |
| Clinical Investigative Site # 6214 | Portland | Oregon | 97213 | United States |
| Clinical Investigative Site 6203 | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Investigative Site # 6228 | Greenville | South Carolina | 29615 | United States |
| Clinical Investigative Site 6230 | Spartanburg | South Carolina | 29303 | United States |
| Clinical Investigative Site 6202 | Knoxville | Tennessee | 37909 | United States |
| Clinical Investigative Site 6226 | Nashville | Tennessee | 37208 | United States |
| Clinical Investigative Site # 6220 | El Paso | Texas | 79903 | United States |
| Clinical Investigative Site # 6225 | Fort Worth | Texas | 76132 | United States |
| Clinical Investigative Site # 6222 | San Antonio | Texas | 78229 | United States |
| Clinical Investigative Site 6229 | San Antonio | Texas | 78229 | United States |
| Clinical Investigative Site # 6217 | Madison | Wisconsin | 53792 | United States |
| Clinical Investigative Site 5002 | Glebe | 2037 | Australia |
| Clinical Investigative Site 5003 | Nedlands | 6009 | Australia |
| Clinical Investigative Site 5001 | Sherwood | 4075 | Australia |
| Clinical Investigative Site # 5103 | Rousse | 7002 | Bulgaria |
| Clinical Investigative Site # 5101 | Sofia | 1431 | Bulgaria |
| Clinical Investigative Site # 5104 | Sofia | 1431 | Bulgaria |
| Clinical Investigative Site # 5102 | Stara Zagora | 6003 | Bulgaria |
| Clinical Investigative Site 5208 | Berlin | 10969 | Germany |
| Clinical Investigative Site 5212 | Berlin | 12165 | Germany |
| Clinical Investigative Site 5205 | Dortmund | 44263 | Germany |
| Clinical Investigative Site 5207 | Gelnhausen | 63571 | Germany |
| Clinical Investigative Site 5211 | Hamburg | 20357 | Germany |
| Clinical Investigative 5209 | Lübeck | 23552 | Germany |
| Clinical Investigative Site 5204 | Mainz | 55116 | Germany |
| Clinical Investigative Site 5202 | Rüdersdorf | 15562 | Germany |
| Clinical Investigative Site 5310 | Budapest | 1036 | Hungary |
| Clinical Investigative Site 5307 | Csorna | 9300 | Hungary |
| Clinical Investigative Site 5304 | Miskolc | 3529 | Hungary |
| Clinical Investigative Site # 5303 | Nyíregyháza | 4400 | Hungary |
| Clinical Investigative Site 5309 | Sátoraljaújhely | 3980 | Hungary |
| Clinical Investigative Site 5301 | Siófok | 8600 | Hungary |
| Clinical Investigative Site # 5308 | Sopron | 9400 | Hungary |
| Clinical Investigative Site # 5305 | Szombathely | H-9700 | Hungary |
| Clinical Investigative Site 5302 | Tatabánya | H-2800 | Hungary |
| Clinical Investigative Site # 5407 | Ashkelon | 78278 | Israel |
| Clinical Investigative Site 5401 | Haifa | 34362 | Israel |
| Clinical Investigative Site # 5402 | Jerusalem | 91120 | Israel |
| Clinical Investigative Site 5405 | Petach Tikvah | 49100 | Israel |
| Clinical Investigative Site # 5403 | Rehovot | 76100 | Israel |
| Clinical Investigative Site # 5404 | Tel Aviv | 64239 | Israel |
| Clinical Investigative Site # 5406 | Tel Aviv | 64239 | Israel |
| Clinical Investigative Site # 5507 | Bialystok | 15-010 | Poland |
| Clinical Investigative Site # 5505 | Krakow | 31-023 | Poland |
| Clinical Investigative Site # 5501 | Lodz | 90-553 | Poland |
| Clinical Investigative Site # 5502 | Lublin | 20-095 | Poland |
| Clinical Investigative Site # 5503 | Tarnów | 33-100 | Poland |
| Clinical Investigative Site 5610 | Barnaul | 656024 | Russia |
| Clinical Investigative Site 5606 | Barnaul | 656045 | Russia |
| Clinical Investigative Site 5603 | Kazan' | 420015 | Russia |
| Clinical Investigative Site 5602 | Moscow | 105077 | Russia |
| Clinical Investigative Site 5654 | Moscow | 105229 | Russia |
| Clinical Investigative Site 5607 | Moscow | 115280 | Russia |
| Clinical Investigative Site 5609 | Novosibirsk | 630037 | Russia |
| Clinical Investigative Site 5605 | Saint Petersburg | 194044 | Russia |
| Clinical Investigative Site 5604 | Saint Petersburg | 197022 | Russia |
| Clinical Investigative Site 5608 | Tomsk | 634034 | Russia |
| Clinical Investigative Site 5701 | Belgrade | 11080 | Serbia |
| Clinical Investigative Site 5702 | Belgrade | 11080 | Serbia |
| Clinical Investigative Site 5802 | Singapore | 529889 | Singapore |
| Clinical Investigative Site 5908 | Bloemfontein | 9300 | South Africa |
| Clinical Investigative Site 5905 | Cape Town | 7530 | South Africa |
| Clinical Ivestigative Site 5902 | Cape Town | 7700 | South Africa |
| Clinical Investigative Site 5901 | Durban | 4001 | South Africa |
| Clinical Investigative Site 5909 | George | 6529 | South Africa |
| Clinical Investigative Site 5906 | Johannesburg | 1829 | South Africa |
| Clinical Investigative Site 5910 | Port Elizabeth | 6045 | South Africa |
| Clinical Investigative Site 5903 | Pretoria | 0157 | South Africa |
| Clinical Investigative Site 5907 | Pretoria | 0181 | South Africa |
| Clinical Investigative Site 6001 | Gothenburg | 413 42 | Sweden |
| Clinical Investigative Site # 6006 | Härnösand | 87182 | Sweden |
| Clinical Investigative Site 6003 | Linköping | 58185 | Sweden |
| Clinical Investigative Site # 6002 | Luleå | 97231 | Sweden |
| Clinical Investigative Site 6052 | Lund | 22185 | Sweden |
| Clinical Investigative Site 6007 | Stockholm | 111 57 | Sweden |
| Clinical Investigative Site 6004 | Varberg | 432 44 | Sweden |
| Clinical Investigative Site # 6104 | Donetsk | 83099 | Ukraine |
| Clinical Investigative Site 6110 | Kharkiv | 61018 | Ukraine |
| Clinical Investigative Site # 6101 | Kharkiv | 61035 | Ukraine |
| Clinical Investigative Site # 6102 | Kyiv | 03680 | Ukraine |
| Clinical Investigative Site # 6103 | Kyiv | 03680 | Ukraine |
| Clinical Ivestigative Site 6111 | Odesa | 65025 | Ukraine |
| Clinical Investigative Site 6108 | Poltava | 36028 | Ukraine |
| Clinical Investigative Site # 6107 | Uzhhorod | 88009 | Ukraine |
| Clinical Investigative Site 6105 | Zaporizhia | 69035 | Ukraine |
| Clinical Investigative Site # 6106 | Zaporizhia | 69118 | Ukraine |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C583159 | 2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido(4,3-b)indol-5(2H)-yl)acetic acid |
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