Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.
The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.
|Asthma||Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446056
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|