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NCT03458130 · ClinicalTrials.gov registry record · Phase 2
Study of AG10 in Amyloid Cardiomyopathy
A Phase 2 study of Familial ATTR-CM (ATTRm-CM, or FAC) and Wild-type ATTR-CM (ATTRwt-CM), sponsored by Eidos Therapeutics, a BridgeBio company.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 13
- Study locations
NCT03458130 is a Phase 2 study of Familial ATTR-CM (ATTRm-CM, or FAC) and Wild-type ATTR-CM (ATTRwt-CM) that has completed, run by Eidos Therapeutics, a BridgeBio company. The registered enrollment target is 49 participants. The trial reports 13 study locations across 10 states.
The verdict
NCT03458130, a Phase 2 study of Familial ATTR-CM (ATTRm-CM, or FAC) and Wild-type ATTR-CM (ATTRwt-CM), has completed, sponsored by Eidos Therapeutics, a BridgeBio company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 13
- Study locations
Study Summary
This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG AG10
Study Locations (13)
California
- Cedars-Sinai Medical Center - Beverly Hills
- Stanford University - Palo Alto
- University of California San Francisco - San Francisco
Massachusetts
- Brigham and Women's Hospital - Boston
- Boston University - Boston
Connecticut
- Yale University - New Haven
Illinois
- Northwestern University - Chicago
Minnesota
- Mayo Clinic - Rochester
New York
- Columbia University - New York
Ohio
- Cleveland Clinic - Cleveland
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03458130
The ClinicalTrials.gov registry entry for NCT03458130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eidos Therapeutics, a BridgeBio company, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Familial ATTR-CM (ATTRm-CM, or FAC) appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03458130 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Massachusetts, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03458130 about?
NCT03458130 is a clinical study titled "Study of AG10 in Amyloid Cardiomyopathy". This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening an...
What is the current status of trial NCT03458130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2018-04-27. Estimated completion is 2018-10-05.
What conditions does trial NCT03458130 study?
This clinical trial studies the following conditions: Familial ATTR-CM (ATTRm-CM, or FAC), Wild-type ATTR-CM (ATTRwt-CM).
What interventions are being tested in trial NCT03458130?
The interventions under investigation include: Placebo Oral Tablet (DRUG), AG10 (DRUG).
Who is sponsoring clinical trial NCT03458130?
This trial is sponsored by Eidos Therapeutics, a BridgeBio company, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03458130 being conducted?
This trial has 13 study locations across California, Connecticut, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Familial ATTR-CM (ATTRm-CM, or FAC)
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Wild-type ATTR-CM (ATTRwt-CM)
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California
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