Status:
COMPLETED
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-2 years
Phase:
PHASE3
Brief Summary
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patien...
Eligibility Criteria
Inclusion
- Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)
- OR:
- 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 had any major surgery 4 weeks prior
- Patient had an allergy to apples or applesauce
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2001
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00943397
Start Date
April 1 2001
End Date
November 1 2001
Last Update
February 3 2022
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