Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

NCT02146378

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Familial Amyloid Poluneuropathy
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

The subjects of this surveillance are all patients who received Vyndaqel.

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


Patients not receive Vyndaqel.

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Transthyretin Familial Amyloid PoluneuropathyVyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT02146378
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official Title VYNDAQEL DRUG USE INVESTIGATION (REGULATORY POST MARKETING COMMITMENT PLAN)
Brief Summary The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.
Detailed Description Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered
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 The subjects of this surveillance are all patients who received Vyndaqel.
Condition Transthyretin Familial Amyloid Poluneuropathy
Intervention Drug: Vyndaqel
20mg/day
Study Groups/Cohorts Vyndaqel
Intervention: Drug: Vyndaqel
Publications * Ishii T, Hirano Y, Matsumoto N, Takata A, Sekijima Y, Ueda M, Ando Y. Characteristics of Patients with Hereditary Transthyretin Amyloidosis and an Evaluation of the Safety of Tafamidis Meglumine in Japan: An Interim Analysis of an All-case Postmarketing Surveillance. Clin Ther. 2020 Aug 12. pii: S0149-2918(20)30333-7. doi: 10.1016/j.clinthera.2020.07.001. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 2, 2020)
495
Original Estimated Enrollment
 (submitted: May 21, 2014)
200
Estimated Study Completion Date April 11, 2022
Estimated Primary Completion Date April 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

The subjects of this surveillance are all patients who received Vyndaqel.

Exclusion Criteria:

Patients not receive Vyndaqel.

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02146378
Other Study ID Numbers B3461042
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020