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Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

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NCT01994889

Last updated on January 24, 2020
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Study Location
The Kirklin Clinic
Birmingham, Alabama, 35249 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin (TTR) Amyloid Cardiomyopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01994889
Pfizer
Active, not recruiting
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Official Title  ICMJE 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 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Transthyretin (TTR) Amyloid Cardiomyopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Tafamidis - 20 mg
    Active Treatment-Low dose
    Intervention: Drug: Tafamidis
  • Experimental: Tafamidis - 80 mg
    Active Treatment-High Dose
    Intervention: Drug: Tafamidis
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Drug: Placebo
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2018) 		441
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013) 		400
Actual Study Completion Date  ICMJE February 7, 2018
Actual Primary Completion Date February 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01994889
Other Study ID Numbers  ICMJE B3461028
2012-002465-35 ( EudraCT Number )
ATTR-ACT ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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