Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy (ATTR-ACT)
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|ClinicalTrials.gov Identifier: NCT01994889|
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Transthyretin (TTR) Amyloid Cardiomyopathy||Drug: Tafamidis Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||441 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||December 9, 2013|
|Primary Completion Date :||February 7, 2018|
|Study Completion Date :||February 7, 2018|
Experimental: Tafamidis - 20 mg
Active Treatment-Low dose
Tafamidis 20 mg in soft gel capsules administered once a day for 30 months
Experimental: Tafamidis - 80 mg
Active Treatment-High Dose
Tafamidis 80 mg in soft gel capsules administered once a day for 30 months
Placebo Comparator: Placebo
Placebo in soft gel capsules administered once a day for 30 months
- All-cause mortality and frequency of cardiovascular-related hospitalization [ Time Frame: From Baseline to Month 30 ]A hierarchical combination of the endpoints for a pooled analysis of the tafamidis treatment groups in comparison to placebo
- 6-Minute Walk Test (6MWT). [ Time Frame: From Baseline to Month 30 ]Change from Baseline to Month 30 in the total distance walked in 6 minutes.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: From Baseline to Month 30 ]Change from Baseline to Month 30 in the Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS).
- Cardiovascular-related mortality [ Time Frame: From Baseline to Month 30 ]The total number of deaths adjudicated as being related to cardiovascular causes.
- Frequency of cardiovascular-related hospitalization [ Time Frame: From Baseline to Month 30 ]The number of times that a subject is hospitalized for cardiovascular-related causes.
- All-cause mortality [ Time Frame: From Baseline to Month 30 ]The total number of deaths in the study.
- TTR stabilization at Month 1 [ Time Frame: From Baseline to Month 1 ]Tafamidis stabilizes the transthyretin (TTR) tetramer by binding with very high affinity to the two thyroxine binding sites, preventing the tetramer from dissociating along the weak dimer-dimer interface. TTR stabilization is a measure of the degree of stabilization afforded the TTR molecule by tafamidis, expressed as a percentage change from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994889
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|