Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00935012 · ClinicalTrials.gov registry record · Phase 3
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy
A Phase 3 study of ATTR-CM and TTR-CM, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 7
- Study locations
NCT00935012: Completed Phase 3 study of ATTR-CM and TTR-CM, sponsored by Pfizer.
NCT00935012 is a Phase 3 study of ATTR-CM and TTR-CM that has completed, run by Pfizer. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00935012, a Phase 3 study of ATTR-CM and TTR-CM, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
- 7
- Study locations
Study Summary
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
Primary Outcome
Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, "How do you feel today as compared to when we talked with you at your last clinic visit for this study?" and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Interventions
- DRUG tafamidis
Study Locations (7)
Illinois
- The University of Chicago Medical Center - Chicago
- University of Chicago Medical Center - Chicago
- University of Chicago - Chicago
Georgia
- Emory University School of Medicine - Atlanta
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
New York
- Clinical Cardiovascular Research Laboratory for the Elderly (CCRLE) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-09-30 |
| Est. Completion | 2019-11-20 |
| Phase | Phase 3 |
What the finished NCT00935012 record still lists
NCT00935012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with ATTR-CM appearing as the primary indexed condition, and to 1 intervention - of which tafamidis is the first listed.
NCT00935012 lists 7 locations in 5 states (Illinois, Georgia, Maryland).
Frequently Asked Questions
What is clinical trial NCT00935012 about?
NCT00935012 is a clinical study titled "Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy". 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-3...
What is the current status of trial NCT00935012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2009-09-30. Estimated completion is 2019-11-20.
What conditions does trial NCT00935012 study?
This clinical trial studies the following conditions: ATTR-CM, TTR-CM.
What interventions are being tested in trial NCT00935012?
The interventions under investigation include: tafamidis (DRUG).
Who is sponsoring clinical trial NCT00935012?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00935012 being conducted?
This trial has 7 study locations across Georgia, Illinois, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ATTR-CM
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00935012's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI