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Safety and Efficacy of Tafami...

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

NCT ID: NCT01994889

Last Updated: 2019-04-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-09

Study Completion Date

2018-02-07

Brief Summary

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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.

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Detailed Description

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Phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind, randomized study to determine efficacy, safety and tolerability of tafamidis on clinical outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Conditions

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Transthyretin (TTR) Amyloid Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tafamidis - 20 mg

Active Treatment-Low dose

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

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

Tafamidis - 80 mg

Active Treatment-High Dose

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

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

Placebo

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tafamidis

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

Intervention Type DRUG

Tafamidis

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,
* Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm,
* Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry

Exclusion Criteria

* A New York Heart Association (NYHA) classification of IV.
* Presence of primary (light chain) amyloidosis.
* Prior liver or heart transplantation or implanted cardiac mechanical assist device.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

UAB Hospital Department of Pharmacy IDS

Birmingham, Alabama, United States

Site Status

University Hospital, University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic Arizona - Mayo Clinic Speciality Building

Phoenix, Arizona, United States

Site Status

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic Arizona - Mayo Clinic Building

Scottsdale, Arizona, United States

Site Status

UCSD Clinical and Translational Research Institute, Investigational Drug Service

La Jolla, California, United States

Site Status

Altman Clinical Translational Research institute

La Jolla, California, United States

Site Status

Altman Clinical Translational Research Institute

La Jolla, California, United States

Site Status

UCSD Sulpizio Cardiovascular Center

La Jolla, California, United States

Site Status

Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Care Foundation

Los Angeles, California, United States

Site Status

UCSF Cardiovascular Care and Prevention Center

San Francisco, California, United States

Site Status

Stanford University Hospital and Clinics

Stanford, California, United States

Site Status

UM Sylvester at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status

University of Miami Hospital & Clinics

Miami, Florida, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Advocate Christ Medical Centre

Oak Lawn, Illinois, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

University of Maryland, School of Medicine

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

The Johns Hopkins Hospital IDS Pharmacy

Baltimore, Maryland, United States

Site Status

Boston Medical Center - Cardiovascular Center, Outpatient Clinic

Boston, Massachusetts, United States

Site Status

Boston Medical Center Investigational Pharmacy Services

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Boston University Medical Center General Clinical Research Unit

Boston, Massachusetts, United States

Site Status

Michigan Medicine,University of Michigan

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic Pharmacy Research Supp

Rochester, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status