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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 93 participants.
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for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study.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.
Interventions
- DRUG Tafamidis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2009-08-05 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00925002
The ClinicalTrials.gov registry entry for NCT00925002 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tafamidis is the first listed.
NCT00925002 reports 0 study locations.
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.
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