Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Public ClinicalTrials.gov record NCT01994889. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01994889
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 441 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 9, 2013 (Actual)
- Primary completion
- Feb 7, 2018 (Actual)
- Completion
- Feb 7, 2018 (Actual)
- Last update posted
- Apr 24, 2019
2013 – 2018
United States locations
- U.S. sites
- 50
- U.S. states
- 21
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirklin Clinic | Birmingham | Alabama | 35249 | — |
| UAB Hospital Department of Pharmacy IDS | Birmingham | Alabama | 35249 | — |
| University Hospital, University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Mayo Clinic Arizona - Mayo Clinic Speciality Building | Phoenix | Arizona | 85054 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Mayo Clinic Arizona - Mayo Clinic Building | Scottsdale | Arizona | 85259 | — |
| UCSD Clinical and Translational Research Institute, Investigational Drug Service | La Jolla | California | 92037-0620 | — |
| Altman Clinical Translational Research institute | La Jolla | California | 92037-0990 | — |
| Altman Clinical Translational Research Institute | La Jolla | California | 92037 | — |
| UCSD Sulpizio Cardiovascular Center | La Jolla | California | 92037 | — |
| Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services | Los Angeles | California | 90048 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Cedars-Sinai Medical Care Foundation | Los Angeles | California | 90211 | — |
| UCSF Cardiovascular Care and Prevention Center | San Francisco | California | 94143 | — |
| Stanford University Hospital and Clinics | Stanford | California | 94305 | — |
| UM Sylvester at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Hospital & Clinics | Miami | Florida | 33136 | — |
| Northwestern Medical Group | Chicago | Illinois | 60611 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Advocate Christ Medical Centre | Oak Lawn | Illinois | 60453 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| University of Maryland, School of Medicine | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| The Johns Hopkins Hospital IDS Pharmacy | Baltimore | Maryland | 21287 | — |
| Boston Medical Center - Cardiovascular Center, Outpatient Clinic | Boston | Massachusetts | 02118 | — |
| Boston Medical Center Investigational Pharmacy Services | Boston | Massachusetts | 02118 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Boston University Medical Center General Clinical Research Unit | Boston | Massachusetts | 02118 | — |
| Michigan Medicine,University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic Pharmacy Research Supp | Rochester | Minnesota | 55905 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| New York University Hospitals | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital | New York | New York | 10029 | — |
| Mount Sinai Doctors Faculty Practice | New York | New York | 10029 | — |
| The Mount Sinai Hospital Department of Pharmacy | New York | New York | 10029 | — |
| Columbia University Medical Center Research Pharmacy | New York | New York | 10032 | — |
| Columbia University Medical Center/Clinical Cardiovascular Research Laboratory for the Elderly | New York | New York | 10034 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | — |
| OHSU Research Pharmacy Services | Portland | Oregon | 97239 | — |
| Oregon Health and Science University (OHSU) | Portland | Oregon | 97239 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Utah,Health Sciences Center | Salt Lake City | Utah | 84132 | — |
| VCU Medical Center - Ambulatory Care Clinic | Richmond | Virginia | 23298 | — |
| VCU Medical Center - Main Hospital | Richmond | Virginia | 23298 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01994889, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2019 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01994889 live on ClinicalTrials.gov.