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NCT00064389 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 746
- Enrollment target
NCT00064389: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00064389 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 746 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064389, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 746 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
Interventions
- DRUG levalbuterol tartrate HFA MDI
- DRUG racemic albuterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2003-01 |
| Est. Completion | 2005-07 |
| Phase | Phase 3 |
What the finished NCT00064389 record still lists
NCT00064389 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which levalbuterol tartrate HFA MDI is the first listed.
NCT00064389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00064389 about?
NCT00064389 is a clinical study titled "Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma". The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
What is the current status of trial NCT00064389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2003-01. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00064389?
The interventions under investigation include: levalbuterol tartrate HFA MDI (DRUG), racemic albuterol (DRUG).
Who is sponsoring clinical trial NCT00064389?
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 NCT00064389's enrollment target sits among peer trials
746 474th of 2000 higher than 1,526 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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