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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 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 48 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00634517
The ClinicalTrials.gov registry entry for NCT00634517 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Armstrong Albuterol Sulfate Inhalation Aerosol is the first listed.
NCT00634517 reports 0 study locations.
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.
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