# Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

> **NCT00943397** · PHASE3 · COMPLETED · sponsor: **Organon and Co** · enrollment: 190 (actual)

## Conditions studied

- Asthma

## Interventions

- **DRUG:** montelukast sodium
- **DRUG:** Comparator: Usual Care

## Key facts

- **NCT ID:** NCT00943397
- **Lead sponsor:** Organon and Co
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2001-04
- **Primary completion:** 2001-10
- **Final completion:** 2001-11
- **Target enrollment:** 190 (ACTUAL)
- **Last updated:** 2022-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00943397

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00943397, "Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)". Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/clinical/NCT00943397. Licensed CC0.

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