Status:
COMPLETED
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-24 years
Phase:
NA
Brief Summary
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2001
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00943683
Start Date
August 1 2000
End Date
February 1 2001
Last Update
February 3 2022
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