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Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
University Hospital, University of Alabama at Birmingham
Birmingham, Alabama, 35249 United States
Contact
1-800-718-1021
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
Completed
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

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Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
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)
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Transthyretin (TTR) Amyloid Cardiomyopathy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
446
February 15, 2018
February 15, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Czech Republic
 
NCT01994889
B3461028
2012-002465-35 ( EudraCT Number )
ATTR-ACT ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

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

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