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Trial record 1 of 1 for:    NCT04108091
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Vyndaqel Capsules Special Investigation (ATTR-CM)

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ClinicalTrials.gov Identifier: NCT04108091
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 26, 2019
First Posted Date September 27, 2019
Last Update Posted Date July 1, 2020
Actual Study Start Date October 3, 2019
Estimated Primary Completion Date April 10, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2019)
The incidence of adverse drug reaction [ Time Frame: 30 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2019)
Number of survival [ Time Frame: 30months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vyndaqel Capsules Special Investigation (ATTR-CM)
Official Title Vyndaqel Capsules Special Investigation - Investigation on Patients With Transthyretin Amyloid Cardiomyopathy
Brief Summary Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who are administered with this drug for the treatment of ATTR-CM
Condition Transthyretin (TTR) Amyloid Cardiomyopathy
Intervention Drug: 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/Cohorts Treatment 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 Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2019)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 10, 2024
Estimated Primary Completion Date April 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04108091
Other Study ID Numbers B3461064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2020