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Vyndaqel Capsules Special Investigation (ATTR-CM)

Last updated on December 11, 2019

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Study Location
Pfizer
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin (TTR) Amyloid Cardiomyopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- N/A

NCT04108091
Pfizer
Recruiting
Vyndaqel Capsules Special Investigation (ATTR-CM)

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Descriptive Information
Brief TitleVyndaqel Capsules Special Investigation (ATTR-CM)
Official TitleDRUG USE INVESTIGATION OF TAFAMIDIS MEGLUMINE FOR TTR-CM (POST MARKETING COMMITMENT PLAN)
Brief SummarySecondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan.
Detailed DescriptionTo 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.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Other
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients who are administered with this drug for the treatment of ATTR-CM
ConditionTransthyretin (TTR) Amyloid Cardiomyopathy
InterventionDrug: 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.
Other Name: Vyndaqel
Study Groups/CohortsTreatment for TTR amyloidosis
Transthyretin amyloid cardiomyopathy (wild-type or variants) patients administered Vyndaqel
Intervention: Drug: Treatment for TTR amyloidosis
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: September 26, 2019)
360
Original Estimated EnrollmentSame as current
Estimated Study Completion DateApril 10, 2024
Estimated Primary Completion DateApril 10, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT04108091
Other Study ID NumbersB3461064
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

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