Official Title: “A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma”

A study to determine the effects of MK0476 on pediatric patient with chronic asthma compared with placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) qd; Patients >2 yrs to <64 mos: 4mg chewable tablet for a 24-wk treatment period.
• Drug: Comparator: placebo (unspecified)
  • Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) Pbo qd; Patients >2 yrs to <64 mos: 4mg chewable tablet Pbo for a 24-wk treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: drug
• Placebo Comparator: 2
  • Arm 2: Pbo comparator

Primary Measures

• Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476.
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment.
  • Time Frame: 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient is between 6 months and 5 years, 4 months of age
• Patient has been diagnosed with asthma by a doctor
• Patient has had at least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

• Patient has active or chronic breathing disease, other than asthma
• Patient required insertion of a breathing tube for asthma
• Patient had major surgery within the last 4 weeks
• Patient is currently in the hospital
• Patient is allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00540839

Study ID Number: 2007_583

ClinicalTrials.gov Identifier: NCT00540839

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site