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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

NCT00636207

Asthma

COMPLETED PHASE1

A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

NCT00140881

Asthma

COMPLETED PHASE4

Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

NCT00092144

Asthma

COMPLETED PHASE3

The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

NCT00739297

Chronic Asthma

COMPLETED PHASE1

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

NCT00229970

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Drug

Group Type EXPERIMENTAL

montelukast

Intervention Type DRUG

One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks

2

Pbo

Group Type PLACEBO_COMPARATOR

placebo (unspecified)

Intervention Type DRUG

Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

montelukast

One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks

Intervention Type DRUG

placebo (unspecified)

Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK0476 SINGULAIR ®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No