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Clinical Trial Summary

Primary Objective:

To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.

Secondary Objective:

To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.


Clinical Trial Description

It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02401191
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date March 2015
Completion date July 2015

See also
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Not yet recruiting NCT05720455 - Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above Phase 4
Completed NCT00446186 - MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378) Phase 2