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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: Completed Phase 3 study, sponsored by Amphastar Pharmaceuticals.
NCT01737905 is a Phase 3 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Bronchodilator effect expressed as AUC of FEV1's relative change from the same day baseline (pre-dose) versus time up to 3 hours, defined as AUC(0-3) of change in FEV1%. The difference of primary endpoints of E004 and Placebo will be evaluated statistically.
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 |
What the finished NCT01737905 record still lists
NCT01737905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo-HFA is the first listed.
NCT01737905 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01737905's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 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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