Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

• Status: Completed
• Trial end date: 2001-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Patient is in good, stable health

• Patient has been fed solid foods for at least 1 month

• Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit

• Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

• Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks