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NCT00925002 · ClinicalTrials.gov registry record · Phase 3
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
NCT00925002: Completed Phase 3 study, sponsored by Pfizer.
NCT00925002 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00925002, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
Study Summary
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for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study.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.
Primary Outcome
NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensatio
Interventions
- DRUG Tafamidis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2009-08-05 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 3 |
What the finished NCT00925002 record still lists
NCT00925002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Tafamidis is the first listed.
NCT00925002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00925002 about?
NCT00925002 is a clinical study titled "Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis". 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, ...
What is the current status of trial NCT00925002?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2009-08-05. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT00925002?
The interventions under investigation include: Tafamidis (DRUG).
Who is sponsoring clinical trial NCT00925002?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00925002's enrollment target sits among peer trials
93 1722nd of 2000 higher than 278 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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