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NCT01460511 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of E004 in Children With Asthma
A Phase 3 study of Asthma, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 8
- Study locations
NCT01460511 is a Phase 3 study of Asthma that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 70 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 4 states.
The verdict
NCT01460511, a Phase 3 study of Asthma, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.
Conditions Studied
Interventions
- DRUG E004 (Epinephrine Inhalation Aerosol) HFA-MDI
- DRUG Placebo-HFA
Study Locations (8)
California
- Amphastar Site 5 - Costa Mesa
- Amphastar Site 8 - Orange
- Amphastar Site 4 - Stockton
Oregon
- Amphastar Site 2 - Medford
- Amphastar Site 1 - Portland
Texas
- Amphastar Site 3 - El Paso
- Amphastar Site 6 - San Antonio
South Carolina
- Amphastar Site 7 - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01460511
The ClinicalTrials.gov registry entry for NCT01460511 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which E004 (Epinephrine Inhalation Aerosol) HFA-MDI is the first listed.
NCT01460511 reports 8 study locations spanning 4 distinct geographic areas - top geographies include California, Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT01460511 about?
NCT01460511 is a clinical study titled "Evaluation of Efficacy and Safety of E004 in Children With Asthma". This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.
What is the current status of trial NCT01460511?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2011-10. Estimated completion is 2012-07.
What conditions does trial NCT01460511 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01460511?
The interventions under investigation include: E004 (Epinephrine Inhalation Aerosol) HFA-MDI (DRUG), Placebo-HFA (DRUG).
Who is sponsoring clinical trial NCT01460511?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01460511 being conducted?
This trial has 8 study locations across California, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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