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NCT03860935 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
A Phase 3 study, sponsored by Eidos Therapeutics, a BridgeBio company.
- Completed
- Registry status
- Phase 3
- Development phase
- 632
- Enrollment target
NCT03860935: Completed Phase 3 study, sponsored by Eidos Therapeutics, a BridgeBio company.
NCT03860935 is a Phase 3 study that has completed, run by Eidos Therapeutics, a BridgeBio company. The registered enrollment target is 632 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860935, a Phase 3 study, has completed, sponsored by Eidos Therapeutics, a BridgeBio company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 632 participants
- Enrollment target
Study Summary
Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
Primary Outcome
The endpoint was analyzed using Finkelstein-Schoenfeld method. The method combines all-cause mortality, cumulative frequency of CV-related hospitalizations, change from baseline in NT-proBNP and change from baseline in 6MWT in a hierarchical fashion. The method compares every participant with every other participant within strata, assigning a +1 to the "better" participant and a -1 to the "worse" participant and 0 if they are "tied". Participants who had heart transplantation or implantation of
Interventions
- DRUG Placebo Oral Tablet
- DRUG acoramidis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 632 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2023-05-11 |
| Phase | Phase 3 |
What the finished NCT03860935 record still lists
NCT03860935 is an interventional study that assigns participants to a tested intervention. The registered 632 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 (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03860935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03860935 about?
NCT03860935 is a clinical study titled "Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy". Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What is the current status of trial NCT03860935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 632 participants. The study started on 2019-03-19. Estimated completion is 2023-05-11.
What interventions are being tested in trial NCT03860935?
The interventions under investigation include: Placebo Oral Tablet (DRUG), acoramidis (DRUG).
Who is sponsoring clinical trial NCT03860935?
This trial is sponsored by Eidos Therapeutics, a BridgeBio company, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03860935's enrollment target sits among peer trials
632 581st of 2000 higher than 1,420 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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