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Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

NCT00968201 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 689

Last updated 2022-02-03

Study results available
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Summary

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Conditions

Interventions

DRUG

montelukast sodium

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

DRUG

Comparator: Placebo

one chewable placebo tablet, once daily at bedtime for 12 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
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-12-31
Primary Completion
2001-03-31
Completion
2001-03-31

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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 NCT00968201 on ClinicalTrials.gov