CLINICAL TRIALS PROFILE FOR TAFAMIDIS
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All Clinical Trials for TAFAMIDIS
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00925002 ↗ | Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis | Completed | Pfizer | Phase 3 | 2009-08-05 | This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers. |
| NCT00935012 ↗ | Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy | Completed | Pfizer | Phase 3 | 2009-09-30 | Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type Transthyretin (ttr) Amyloid Cardiomyopathy. Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on Day 0, patients will have their entrance criteria reviewed, and medical histories and demographic characteristics obtained. The physical examination (including weight and vital signs) and the relevant end of study clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than 30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical laboratory assessments must be performed on Day 0. Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months. Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated physical examinations (including weight and vital signs) will also be performed at each 6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone call will be made at 3-month intervals between clinic visits to assess safety and use of concomitant medications. For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ, 6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition, echocardiograms will be performed every 12 months on an annual basis. An end of study visit including all safety and efficacy assessments will occur upon patient completion of the study, premature withdrawal (for any reason), or in the event of program discontinuation by the Sponsor. |
| NCT01369836 ↗ | Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects | Completed | Pfizer | Phase 1 | 2011-07-01 | The purpose of this study is the following: - To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose. - To compare Japanese and Western PK profiles. - Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay. |
| NCT01435655 ↗ | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin | Completed | Pfizer | Phase 3 | 2011-11-01 | Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer. |
| NCT01655511 ↗ | Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers | Completed | Pfizer | Phase 1 | 2012-07-01 | This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis |
| NCT01775761 ↗ | A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc) | Completed | Pfizer | Phase 1 | 2013-01-01 | The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers. |
| NCT01994889 ↗ | Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy | Completed | Pfizer | Phase 3 | 2013-12-09 | 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. |
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