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NCT01404234 · ClinicalTrials.gov registry record · Phase 3
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT01404234 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 61 participants.
The verdict
NCT01404234, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.
Interventions
- DRUG AZLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01404234
The ClinicalTrials.gov registry entry for NCT01404234 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AZLI is the first listed.
NCT01404234 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01404234 about?
NCT01404234 is a clinical study titled "Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways". This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. ...
What is the current status of trial NCT01404234?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2011-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01404234?
The interventions under investigation include: AZLI (DRUG).
Who is sponsoring clinical trial NCT01404234?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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