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Tiny study checks heart drug safety in india

NCT ID NCT06086353

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety of a drug called Tafamidis (brand name VyndaMx) in 6 people in India with a rare heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In ATTR-CM, faulty proteins build up in the heart and make it harder to pump blood. Researchers tracked side effects for 6 months after patients started taking the drug. The goal was simply to see if the drug is safe in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tafamidis (VyndaMx) capsules
What this could lead to
If successful, this study could confirm that Tafamidis is safe for use in Indian patients with ATTR-CM, supporting its continued use.
What could go wrong
This was a very small study (only 6 participants) and only looked at safety, not effectiveness. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

6 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). * Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM. Exclusion Criteria: * Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product. * Patients with rare hereditary problems of fructose intolerance. * Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.

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Conditions

The condition(s) this trial relates to.

wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloid cardiomyopathy

Contacts and locations

Locations

  • AIG Hospital

    Hyderabad, 500032, India

  • Max Super Speciality Hospital

    New Delhi, 110017, India

  • Sri Jayadeva Institute of Cardiovascular Sciences and Research

    Bangalore, Karnataka, 560069, India

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