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This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Drug | Active Comparator | ACT-129968 |
|
| Comparative Drug | Placebo Comparator | matching placebo tablets and capsules |
|
| Reference Drug | Active Comparator | Cetirizine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-129968 | Drug | daily tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in Daytime Nasal Symptom Score | baseline to end of treatment period (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in other daytime/nighttime symptom scores of allergic rhinitis | baseline to end of treatment period (2 weeks) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Grabo, PhD | 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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| Placebo | Drug | matching placebo tablets and capsules |
|
| Cetirizine | Drug | daily capsules |
|
| 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 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| 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 |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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