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NCT01458119 · ClinicalTrials.gov registry record · Phase 3
Open-Label Phase 3 Long-Term Safety Study of Migalastat
A Phase 3 study, sponsored by Amicus Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
NCT01458119 is a Phase 3 study that was terminated before completion, run by Amicus Therapeutics. The registered enrollment target is 85 participants.
The verdict
NCT01458119, a Phase 3 study, was terminated before completion, sponsored by Amicus Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
Study Summary
This was a long-term, open-label study of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
Interventions
- DRUG migalastat hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2011-10-14 |
| Est. Completion | 2016-02-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458119
The ClinicalTrials.gov registry entry for NCT01458119 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which migalastat hydrochloride is the first listed.
NCT01458119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01458119 about?
NCT01458119 is a clinical study titled "Open-Label Phase 3 Long-Term Safety Study of Migalastat". This was a long-term, open-label study of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
What is the current status of trial NCT01458119?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2011-10-14. Estimated completion is 2016-02-17.
What interventions are being tested in trial NCT01458119?
The interventions under investigation include: migalastat hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01458119?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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