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Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

NCT03860935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2024-06-27

Study results available
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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).

Conditions

  • Amyloidosis
  • Amyloid Cardiomyopathy
  • Transthyretin Amyloidosis
  • Cardiomyopathies
  • Heart Diseases

Interventions

DRUG

acoramidis

TTR stabilizer administered orally twice daily (BID)

DRUG

Placebo Oral Tablet

Non-active control administered orally twice daily (BID)

Sponsors & Collaborators

  • Eidos Therapeutics, a BridgeBio company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2023-05-11
Completion
2023-05-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Greece
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03860935 on ClinicalTrials.gov