Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01306721 | Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis | PHASE3 | COMPLETED | 520 | — | — | Feb 1, 2011 | Apr 1, 2011 | Oct 16, 2013 | 3 | Japan |
| Arm | Type | Description |
|---|---|---|
| FEX 60 mg | ACTIVE_COMPARATOR | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 60 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 120 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg |
| Name | Type | Description |
|---|---|---|
| fexofenadine HCL (M016455) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| fexofenadine HCL matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: \- Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years Exclusion criteria: * At the start of the placebo lead-in period: * Patients who are negative for IgE Ant...