Trial · NCT00925002
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
NCT00925002, Phase 3, Completed, Pfizer; results first posted 2021-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis. Trials, record NCT00925002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00925002
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
- NCT number
- NCT00925002
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 93 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ATTR-PN
- Interventions
- Tafamidis
- First posted
- 2009-06-19
- Last updated
- 2021-07-29
- Other registries' IDs
- eudract:2009-011535-12
- Results first posted
- 2021-07-29
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005) | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30 | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66 | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201) | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12 | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12 | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60 | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60 | 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); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment. |
| Primary | Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline | Baseline of B3461020 (Fx-005) | Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL. |
| Primary | Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30 | Baseline of B3461020 (Fx-005), Month 30 | Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL. |
| Primary | Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66 | Baseline of B3461020 (Fx-005), Month 66 | Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL. |
| Primary | NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline | Baseline of B3461022 (Fx1A-201) | Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005) | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. | units on a scale | MEAN |
| PRIMARY | Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 | Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201) | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. | units on a scale | MEAN |
| PRIMARY | NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12 | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60 | Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline | Baseline of B3461020 (Fx-005) | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30 | Baseline of B3461020 (Fx-005), Month 30 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66 | Baseline of B3461020 (Fx-005), Month 66 | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline | Baseline of B3461022 (Fx1A-201) | ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. | units on a scale | MEAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group1,030
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Val30Met: Tafamidis Then Tafamidis | 6.8 | Standard Deviation 10.8 | units on a scale | |
| Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | Val30Met: Placebo Then Tafamidis | 11.6 | Standard Deviation 14.1 | units on a scale | |
| Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 | Val30Met: Tafamidis Then Tafamidis | 3.8 | Standard Error 1.5 | units on a scale | |
| Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 | Val30Met: Placebo Then Tafamidis | 6.4 | Standard Error 1.6 | units on a scale | |
| Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 | Val30Met: Tafamidis Then Tafamidis | 7.8 | Standard Error 1.6 | units on a scale | |
| Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 | Val30Met: Placebo Then Tafamidis | 11.3 | Standard Error 1.6 | units on a scale | |
| NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline | NonVal30Met: Tafamidis | 31.1 | Standard Deviation 24.4 | units on a scale | |
| NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12 | NonVal30Met: Tafamidis | 2.5 | Standard Error 2.0 | units on a scale | |
| NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60 | NonVal30Met: Tafamidis | 12.0 | Standard Error 2.7 | units on a scale | |
| Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline | Val30Met: Tafamidis Then Tafamidis | 24.1 | Standard Deviation 26.3 | units on a scale |
1 to 10 of 1,030Source ClinicalTrials.gov
See all 1,030 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Val30Met: Tafamidis Then Tafamidis | 38 | |
| Overall Study | STARTED | Val30Met: Placebo Then Tafamidis | 37 | |
| Overall Study | STARTED | NonVal30Met: Tafamidis | 18 | |
| Overall Study | Treated | Val30Met: Tafamidis Then Tafamidis | 38 | |
| Overall Study | Treated | Val30Met: Placebo Then Tafamidis | 37 | |
| Overall Study | Treated | NonVal30Met: Tafamidis | 18 | |
| Overall Study | COMPLETED | Val30Met: Tafamidis Then Tafamidis | 32 | |
| Overall Study | COMPLETED | Val30Met: Placebo Then Tafamidis | 28 | |
| Overall Study | COMPLETED | NonVal30Met: Tafamidis | 8 | |
| Overall Study | NOT COMPLETED | Val30Met: Tafamidis Then Tafamidis | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events645
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Val30Met: Tafamidis Then Tafamidis | 2 | 38 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Val30Met: Placebo Then Tafamidis | 1 | 37 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | NonVal30Met: Tafamidis | 0 | 18 | 0 |
| other | Arrhythmia | Cardiac disorders | Val30Met: Tafamidis Then Tafamidis | 2 | 38 | 2 |
| other | Arrhythmia | Cardiac disorders | Val30Met: Placebo Then Tafamidis | 0 | 37 | 0 |
| other | Arrhythmia | Cardiac disorders | NonVal30Met: Tafamidis | 0 | 18 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Val30Met: Tafamidis Then Tafamidis | 2 | 38 | 2 |
| other | Atrial Fibrillation | Cardiac disorders | Val30Met: Placebo Then Tafamidis | 0 | 37 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | NonVal30Met: Tafamidis | 0 | 18 | 0 |
| other | Bundle Branch Block Bilateral | Cardiac disorders | Val30Met: Tafamidis Then Tafamidis | 0 | 38 | 0 |
1 to 10 of 645Source ClinicalTrials.gov
See all 645 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Val30Met: Tafamidis Then Tafamidis | 3 | 38 |
| Total, all-cause mortality | Val30Met: Placebo Then Tafamidis | 1 | 37 |
| Total, all-cause mortality | NonVal30Met: Tafamidis | 7 | 18 |
| Total, other adverse events | Val30Met: Tafamidis Then Tafamidis | 34 | 38 |
| Total, other adverse events | Val30Met: Placebo Then Tafamidis | 32 | 37 |
| Total, other adverse events | NonVal30Met: Tafamidis | 18 | 18 |
| Total, serious adverse events | Val30Met: Tafamidis Then Tafamidis | 6 | 38 |
| Total, serious adverse events | Val30Met: Placebo Then Tafamidis | 9 | 37 |
| Total, serious adverse events | NonVal30Met: Tafamidis | 10 | 18 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00925002
GET https://conductscience.org/api/trials/v1/NCT00925002/registered?page=2