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NCT01315236 · ClinicalTrials.gov registry record · Phase 2
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
A Phase 2 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01315236 is a Phase 2 study that has completed, run by Insmed Incorporated. The registered enrollment target is 90 participants.
The verdict
NCT01315236, a Phase 2 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints.
Interventions
- DRUG placebo
- DRUG Liposomal amikacin for inhalation (LAI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2012-04-19 |
| Est. Completion | 2015-06-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01315236
The ClinicalTrials.gov registry entry for NCT01315236 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Incorporated, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01315236 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01315236 about?
NCT01315236 is a clinical study titled "Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria". The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoi...
What is the current status of trial NCT01315236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2012-04-19. Estimated completion is 2015-06-18.
What interventions are being tested in trial NCT01315236?
The interventions under investigation include: placebo (DRUG), Liposomal amikacin for inhalation (LAI) (DRUG).
Who is sponsoring clinical trial NCT01315236?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
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