clinical trial · NCT00446056
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Organon and Co·phase4·completed·n = 188
AsthmaMK0476, montelukast sodium / Duration of Treatment: 4 WeeksComparator: ketotifen / Duration of Treatment: 4 Weeks
brief summary
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.
started
Sep 25, 2003
primary completion
Jun 16, 2004
completion
Jun 16, 2004
last updated
Aug 15, 2024
official title
Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol