Clinical Trial Details

NCT ID: NCT02791230
Date Last Changed: September 29, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Tafamidis meglumine for the treatment of Transthyretin (TTR) Amyloid Cardiomyopathy

Research Study Title

A Phase 3 Multicenter, Randomized, Double-blind, Extension Study To Evaluate The Safety Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

Purpose

Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 90 Years
Overall Status
Recruiting
Lead Sponsor
Pfizer
Duration
66 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 90 Years

Inclusion Criteria:

-Completion of 30 months of study treatment on Pfizer Protocol B3461028

Exclusion Criteria:

-Liver and/or heart transplant, or implanted cardiac mechanical assist device

Site Locations (50)

Country State City Zip Facility and Contact
United States California La Jolla 92037 Altman Clinical Translational Research Institute
United States California La Jolla 92037 UCSD Sulpizio Cardiovascular Center
United States California La Jolla 92037 University of California, San Diego Clinical and Translational Research Institute -
United States California San Diego 92103 University of California, San Diego Medical Center - Hillcrest
United States California San Francisco 94143 UCSF Ambulatory Care Center
United States California San Francisco 94143 University of California
United States California San Francisco 94158 UCSF Cardiovascular Care and Prevention Center
United States California Stanford 94305 Stanford Hospital and Clinics Investigational Pharmacy
United States California Stanford 94305 Stanford University Hospital and Clinics
United States Florida Deerfield Beach 33442 Sylvester at Deerfield Beach
United States Florida Miami 33136 University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center
United States Illinois Chicago 60611 Northwestern Medical Group
United States Illinois Chicago 60611 Northwestern Memorial Hospital
United States Illinois Chicago 60611 Northwestern University
United States Maryland Baltimore 21201 University of Maryland, Baltimore
United States Maryland Baltimore 21287 Johns Hopkins Hospital IDS Pharmacy
United States Maryland Baltimore 21287 Johns Hopkins Hospital
United States Massachusetts Boston 02118 Boston Medical Center Investigational Pharmacy
United States Massachusetts Boston 02118 Boston Medical Center
United States Massachusetts Boston 02118 Boston University Medical Center
United States Michigan Ann Arbor 48109-5853 University of Michigan Hospital
United States Michigan Ann Arbor 48109 University of Michigan Hospital
United States Minnesota Rochester 55902 Mayo Clinic Hospital-Rochester
United States Minnesota Rochester 55905 Mayo Clinic
United States New Jersey Newark 07112 Newark Beth Israel Medical Center
United States New York New York 10032 Columbia University Medical Center Research Pharmacy
United States New York New York 10034 Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly
United States North Carolina Durham 27710 Duke University
United States Ohio Cleveland 44195 Cleveland Clinic
United States Pennsylvania Philadelphia 19104 Penn Presbyterian Medical Center
United States Tennessee Nashville 37232 Vanderbilt University Medical Center
United States Utah Salt Lake City 84112 University of Utah
United States Utah Salt Lake City 84132 University of Utah Medical Center
Czechia Praha 4 140 21 Institut klinicke a experimentalni mediciny
France Clamart 92140 Hopital Antoine Beclere
France Clamart 92140 Hôpital Antoine Béclère
France Creteil 94010 CHU Henri Mondor
Germany Heidelberg 69120 Medical University of Heidelberg
Germany Heidelberg 69120 Medizinisches Universitätsklinikum Heidelberg
Germany Muenster 48149 Universitaetsklinikum Muenster
Italy Bologna 40138 Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
Italy Bologna 40138 Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi
Italy Firenze 50134 Azienda Ospedaliera Universitaria Careggi
Japan Fukuoka Kurume-shi 830-0011 Kurume University Hospital
Japan Kumamoto Kumamoto-city 860-8556 Kumamoto University Hospital
Japan Nagano 390-8621 Shinshu University Hospital
Spain Madrid Majadahonda 28222 Hospital Universitario Puerta de Hierro Majadahonda
Sweden Skellefteå 931 86 Skellefteå Lasarett
United Kingdom London EC1A 7BE Barts Health NHS Trust, St Bartholomew's Hospital
United Kingdom London EC1A 7BE Barts Health NHS Trust, St Batholomew's Hospital

Contact

Pfizer CT.gov Call Center
1-800-718-1021
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.