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This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational drug - Dose 1 | Experimental |
| |
| Investigational drug - Dose 2 | Experimental |
| |
| Investigational drug - Dose 3 | Experimental |
| |
| Investigational Drug - Dose 4 | Experimental |
| |
| Active Matching Reference | Other |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-129968 | Drug | ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo | Baseline to week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo. | Baseline to week 2 |
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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 7905 | Austin | Texas | 78731 | United States | ||
| Clinical Investigative Site 7907 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28392807 | Derived | Ratner P, Andrews CP, Hampel FC, Martin B, Mohar DE, Bourrelly D, Danaietash P, Mangialaio S, Dingemanse J, Hmissi A, van Bavel J. Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies. Allergy Asthma Clin Immunol. 2017 Apr 4;13:18. doi: 10.1186/s13223-017-0183-z. eCollection 2017. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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 |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ACT-129968 | Drug | ACT-129968 (Dose 4) & matching placebo administered orally once daily |
|
| Cetirizine | Drug | Ceterizine administered once daily |
|
| Placebo | Drug | Matching placebo administered twice daily. |
|
| Kerrville |
| Texas |
| 78028 |
| United States |
| Clinical Investigative Site 7903 | New Braunfels | Texas | 78130 | United States |
| Clinical Investigative Site 7901 | San Antonio | Texas | 78229 | United States |
| Clinical Investigative Site 7902 | San Antonio | Texas | 78229 | United States |
| Clinical Investigative Site 7904 | San Antonio | Texas | 78229 | United States |
| Clinical Investigative Site 7906 | San Antonio | Texas | 78229 | United States |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |