Vyndaqel Capsules Special Investigation (ATTR-CM)

NCT ID: NCT04108091

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-03

Study Completion Date

2025-03-27

Brief Summary

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Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.

Detailed Description

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To comprehend information on the long-term safety (e.g., onset status of adverse reactions), etc. of patients who are treated with Vyndaqel for the treatment of transthyretin amyloid cardiomyopathy. When Vynmac is used, conduct the study to grasp information on safety (e.g., onset status of adverse reactions),etc. during the observation period.

Conditions

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Transthyretin (TTR) Amyloid Cardiomyopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Treatment for TTR amyloidosis

Transthyretin amyloid cardiomyopathy (wild-type or variants) patients administered Vyndaqel and Vynmac.

Treatment for TTR amyloidosis

Intervention Type DRUG

The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.

Treatment for TTR amyloidosis

Intervention Type DRUG

The usual adult dose is 61 mg of tafamidis orally once daily.

Interventions

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Treatment for TTR amyloidosis

The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.

Intervention Type DRUG

Treatment for TTR amyloidosis

The usual adult dose is 61 mg of tafamidis orally once daily.

Intervention Type DRUG

Other Intervention Names

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Vyndaqel Vynmac

Eligibility Criteria

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Inclusion Criteria

* Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion Criteria

* N/A
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B3461064

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Other Identifiers

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NCT04108091

Identifier Type: REGISTRY

Identifier Source: secondary_id

B3461064

Identifier Type: -

Identifier Source: org_study_id

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