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NCT00634517 · ClinicalTrials.gov registry record · Phase 3
4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma
A Phase 3 study, sponsored by Amphastar Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT00634517: Clinical Trial Phase 3 study, sponsored by Amphastar Pharmaceuticals.
NCT00634517 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634517, a Phase 3 study, was terminated before completion, sponsored by Amphastar Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this population will be evaluated using a population PK approach with sparse blood samples.
Interventions
- DRUG Armstrong Albuterol Sulfate Inhalation Aerosol
- DRUG Albuterol Sulfate Inhalation Aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Why NCT00634517 stopped before completion
NCT00634517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Armstrong Albuterol Sulfate Inhalation Aerosol is the first listed.
NCT00634517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00634517 about?
NCT00634517 is a clinical study titled "4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma". This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this po...
What is the current status of trial NCT00634517?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2008-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00634517?
The interventions under investigation include: Armstrong Albuterol Sulfate Inhalation Aerosol (DRUG), Albuterol Sulfate Inhalation Aerosol (DRUG).
Who is sponsoring clinical trial NCT00634517?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00634517's enrollment target sits among peer trials
48 1862nd of 2000 higher than 134 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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