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Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
The Kirkland Clinic of UAB Hospital
Birmingham, Alabama, 35233 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

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

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

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

NCT02791230
Pfizer
Recruiting
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

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Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
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)
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
Global, Phase 3, double-blind, randomized, long-term extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with transthyretin cardiomyopathy (TTR-CM), who have completed 30 months of study treatment on Pfizer protocol B3461028, for up to 60 months or until local access to tafamidis for TTR-CM via prescription, whichever occurs first
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 meglumine
Soft gel capsules administered once a day for 60 months
Other Name: tafamidis
  • Experimental: Tafamidis meglumine - 20 mg
    Active Treatment
    Intervention: Drug: Tafamidis meglumine
  • Experimental: Tafamidis meglumine - 40 mg
    Active Treatment
    Intervention: Drug: Tafamidis meglumine
  • Experimental: Tafamidis meglumine - 80 mg
    Active treatment
    Intervention: Drug: Tafamidis meglumine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
December 31, 2021
December 23, 2021   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium,   Czechia,   France,   Germany,   Italy,   Japan,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT02791230
B3461045
2016-000868-42 ( EudraCT 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
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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