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NCT03729362 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease
A Phase 3 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT03729362: Completed Phase 3 study, sponsored by Amicus Therapeutics.
NCT03729362 is a Phase 3 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03729362, a Phase 3 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study Summary
This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.
Primary Outcome
The efficacy of cipaglucosidase alfa/miglustat co-administration on ambulatory function was measured by the 6MWT. The 6MWD, measured in meters, is the distance walked on the 6MWT. A greater distance indicated greater endurance. An increase from baseline indicated improvement.
Interventions
- DRUG Placebo
- DRUG Miglustat
- BIOLOGICAL Cipaglucosidase Alfa
- BIOLOGICAL Alglucosidase Alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2021-01-15 |
| Phase | Phase 3 |
What the finished NCT03729362 record still lists
NCT03729362 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03729362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03729362 about?
NCT03729362 is a clinical study titled "A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease". This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.
What is the current status of trial NCT03729362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2018-12-04. Estimated completion is 2021-01-15.
What interventions are being tested in trial NCT03729362?
The interventions under investigation include: Placebo (DRUG), Miglustat (DRUG), Cipaglucosidase Alfa (BIOLOGICAL), Alglucosidase Alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT03729362?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03729362's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 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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