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NCT01737905 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
A Phase 3 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT01737905 is a Phase 3 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 28 participants.
The verdict
NCT01737905, a Phase 3 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single dose study in 24 pediatric patients (4-11 years old) with asthma. The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study Visits. All study subjects must be properly consented, under adult supervision, and screened against the inclusion and exclusion criteria, at the Screening Visit.
Interventions
- DRUG Placebo-HFA
- DRUG Epinephrine HFA-MDI (E004)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01737905
The ClinicalTrials.gov registry entry for NCT01737905 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 28 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 Placebo-HFA is the first listed.
NCT01737905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01737905 about?
NCT01737905 is a clinical study titled "Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma". This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single dose study in 24 pediatric patients (4-11 years old) with asthma. The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study Visits. All study subjects must be properly conse...
What is the current status of trial NCT01737905?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2012-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01737905?
The interventions under investigation include: Placebo-HFA (DRUG), Epinephrine HFA-MDI (E004) (DRUG).
Who is sponsoring clinical trial NCT01737905?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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