| 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 |
| |
| 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 |
