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

NCT00943683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2022-02-03

Study results available
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Summary

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

Conditions

Interventions

DRUG

montelukast sodium

Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks

DRUG

Comparator: Placebo

Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2001-02-28
Completion
2001-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943683 on ClinicalTrials.gov