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A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00700661
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Condition or disease Intervention/treatment Phase
Asthma Drug: montelukast Drug: placebo (unspecified) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
Study Start Date : January 2001
Primary Completion Date : December 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug
Drug: montelukast
One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
Other Names:
  • MK0476
  • SINGULAIR ®
Placebo Comparator: 2
Pbo
Drug: placebo (unspecified)
Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks



Primary Outcome Measures :
  1. asthma episodes in 2 - 5 year old children [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. the number of treatments and duration of asthma episodes [ Time Frame: at 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female between and including the ages of 2 and 5 years
  • Patient was treated with steroids for an asthma episode in the last 3 months
  • Patient was admitted to the hospital or emergency room in the last 3 months
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient has been in a research study in the past 4 weeks
  • Patient has visited the emergency room for an asthma episode in the past week
  • Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700661


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00700661     History of Changes
Other Study ID Numbers: 0476-907
MK0476-907
2007_572
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action