MedTrace Logo

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

NCT01994889 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2019-04-24

Study results available
· View outcomes & findings →

Summary

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Conditions

  • Transthyretin (TTR) Amyloid Cardiomyopathy

Interventions

DRUG

Tafamidis

Tafamidis 20 mg in soft gel capsules administered once a day for 30 months

DRUG

Tafamidis

Tafamidis 80 mg in soft gel capsules administered once a day for 30 months

DRUG

Placebo

Placebo in soft gel capsules administered once a day for 30 months

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

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
2013-12-09
Primary Completion
2018-02-07
Completion
2018-02-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01994889 on ClinicalTrials.gov