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NCT00809757 · ClinicalTrials.gov registry record · Phase 3
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 197
- Enrollment target
NCT00809757: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00809757 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 197 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00809757, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 197 participants
- Enrollment target
Study Summary
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.
Primary Outcome
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
Interventions
- DRUG Placebo
- DRUG Levalbuterol
- DRUG Levalbuterol UDV TID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00809757 record still lists
NCT00809757 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00809757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00809757 about?
NCT00809757 is a clinical study titled "A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma". A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.
What is the current status of trial NCT00809757?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 197 participants. The study started on 2008-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00809757?
The interventions under investigation include: Placebo (DRUG), Levalbuterol (DRUG), Levalbuterol UDV TID (DRUG).
Who is sponsoring clinical trial NCT00809757?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00809757's enrollment target sits among peer trials
197 1390th of 2000 higher than 611 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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