drugset / Trial / NCT01640535

Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

NCT01640535

Phase 3 Completed 283 enrolled Hanmi Pharmaceutical Company Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.

Timeline

Start
2012-06
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Levocetirizine Unknown 5 mg
Subject Montelukast Other / unclassified 10 mg