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This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DL | Experimental | Desloratadine syrup once daily |
|
| Placebo | Placebo Comparator | placebo syrup once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desloratadine | Drug | desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerance | Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36. | Days 15 and Days 36 |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subjects who:
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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|
| Placebo | Drug | placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days. |
|
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |