← Back to Search

Transthyretin Stabilizer

Tafamidis for Cardiomyopathy

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 60

Awards & highlights

Study Summary

This trial will test tafamidis, a potential treatment for transthyretin cardiomyopathy, a heart condition.

Who is the study for?

This trial is for two groups: Cohort A, who finished 30 months in a previous Pfizer study, and Cohort B, patients from certain countries with transthyretin cardiomyopathy (ATTR-CM) but not in the prior study. Those with heart or liver transplants or mechanical heart devices can't join.Check my eligibility

What is being tested?

The trial is testing Tafamidis's long-term safety for treating ATTR-CM. It's an open-label study, meaning everyone knows they're getting Tafamidis and there are no placebos or comparison drugs involved.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally such medications could cause issues like gastrointestinal symptoms, potential liver problems, and possibly nerve-related symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-cause mortality and incidence of treatment emergent adverse events

Other outcome measures

All-cause hospitalization

Body Mass Index/modified Body Mass Index

Cardiac biomarkers

+4 more

Side effects data

From 2020 Phase 3 trial • 93 Patients • NCT00925002

16%

Thermal Burn

16%

Urinary Tract Infection

13%

Back Pain

13%

Nasopharyngitis

11%

Infected Skin Ulcer

11%

Headache

11%

Abdominal Distension

11%

Vomitting

11%

Urinary Retention

Depression

Wound Infection

Vertigo

Dizziness

Upper Respiratory Tract Infection

Balance Disorder

Gait Disturbance

Burn Infection

Influenza

Cough

Nausea

Vaginal Infection

Renal Failure

Constipation

Oedema Peripheral

Skin Infection

Muscle Spasms

Paraesthesia

Skin Ulcer

Limb Injury

Arrhythmia

Conjunctivitis

Cardiac Failure

Eye Pruritus

Abdominal Pain Upper

Diarrhoea

Early Satiety

Haemorrhoids

Pain in Extremity

Dry Mouth

Pharyngitis

Anaemia

Blister

Tendonitis

Insomnia

Dyspnoea

Orthostatic Hypotension

Transient Ischaemic Attack

Atrial Fibrillation

Vision Blurred

Procedural Pain

Arthralgia

Arthritis

Neuralgia

Acne

Mitral Valve Incompetence

Gastritis

Ear Infection

Gastroenteritis

Muscular Weakness

Traumatic Ulcer

Weight Decreased

Walking Disability

Gamma-Glutamyltransferase Increased

Device Related Infection

Pericardial Effusion

Concussion

Vertigo Positional

Inguinal Hernia

Lymphoma

Hepatomegaly

Cardiomyopathy

Gastrointestinal Motility Disorder

Pleural Effusion

Pyrexia

Alanine Aminotransferase Increased

Cholangitis

Decreased Appetite

Central Nervous System Lymphoma

Muscle Atrophy

Hypokalaemia

Hypotension

Burning Sensation

Skin Abrasion

Dysuria

Erectile Dysfunction

Alopecia

Decubitus Ulcer

Angina Unstable

Ventricular Tachycardia

Syncope

Rash

Hypoalbuminaemia

Palpitations

Ascites

Chest Pain

Fall

Aspartate Aminotransferase Increased

Vitamin D Deficiency

Renal Impairment

Fatigue

Tooth Abscess

Skin Laceration

Musculoskeletal Chest Pain

Neuropathy Peripheral

Nephrolithiasis

Dementia Alzheimer's Type

Pneumonia

Febrile Neutropenia

Abdominal Pain

100%

80%

60%

40%

20%

Study treatment Arm

Val30Met: Placebo Then Tafamidis

Val30Met: Tafamidis Then Tafamidis

NonVal30Met: Tafamidis

Trial Design

1Treatment groups

Experimental Treatment

Group I: TafamidisExperimental Treatment1 Intervention

Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tafamidis

2018

Completed Phase 4

~2400

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,568 Previous Clinical Trials

10,910,151 Total Patients Enrolled

4 Trials studying Transthyretin Amyloid Cardiomyopathy

402 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,091,319 Total Patients Enrolled

4 Trials studying Transthyretin Amyloid Cardiomyopathy

402 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

Media Library

Tafamidis (Transthyretin Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT02791230 — Phase 3

Transthyretin Amyloid Cardiomyopathy Research Study Groups: Tafamidis

Transthyretin Amyloid Cardiomyopathy Clinical Trial 2023: Tafamidis Highlights & Side Effects. Trial Name: NCT02791230 — Phase 3

Tafamidis (Transthyretin Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02791230 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there Tafamidis any dangers that patients should be made aware of?

"Tafamidis received a score of 3 on Power's safety scale. This is due to the fact that Tafamidis is in Phase 3 clinical trials, meaning that there is both efficacy and safety data supporting its use."

Answered by AI

How many patients are included in this research project?

"This specific study is no longer recruiting patients, as seen from the last update on December 6th, 2021. The original posting was on June 13th, 2016. However, there are other 176 clinical trials for transthyretin (ttr) amyloid cardiomyopathy and 5 studies for Tafamidis that are still looking for participants."

Answered by AI

Is this experiment still looking for participants?

"This particular study is not looking for more patients at the moment. It was originally posted on June 13th, 2016 but has since been edited December 6th, 2021. There are other ongoing trials you may be eligible for, including 176 trials recruiting patients with transthyretin (ttr) amyloid cardiomyopathy and 5 studies for Tafamidis which are actively enrolling patients."

Answered by AI

Are there many different hospitals participating in this experiment across America?

"Currently, there are 50 sites enrolling patients for this trial. In addition to locations in Chicago, Portland and San Francisco; other enrolment centres can be found in 50 different cities. If you are considering participation, it is best to choose a location near you to avoid extensive travel."

Answered by AI

What are the implications of this trial's findings?

"As of now, there are 5 ongoing studies for Tafamidis in 18 different countries and 46 cities. The first trial happened in 2016 and was completed by Pfizer. A total of 1637 people participated in the study which reached Phase 3 drug approval. In the 4 years since the initial study, 31 more trials have been conducted."

Answered by AI

What other scientific investigations have been conducted using Tafamidis?

"The first trial for Tafamidis was conducted in 2016 at the Montreal Heart Institute-Research Center. As of now, there have been 31 completed studies with 5 more trials currently underway. The majority of these active trials are taking place in Chicago, Illinois."

Answered by AI