Trials / Completed
CompletedNCT00943683
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2000-08-01
- Primary completion
- 2001-02-01
- Completion
- 2001-02-01
- First posted
- 2009-07-22
- Last updated
- 2022-02-03
- Results posted
- 2010-06-17
Source: ClinicalTrials.gov record NCT00943683. Inclusion in this directory is not an endorsement.