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Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Last updated on July 30, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT02146378
Pfizer
Active, not recruiting
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
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.
Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered
Observational
Observational Model: Case-Only
Time Perspective: Other
Not Provided
Not Provided
Probability Sample
The subjects of this surveillance are all patients who received Vyndaqel.
Transthyretin Familial Amyloid Poluneuropathy
Drug: Vyndaqel
20mg/day
Vyndaqel
Intervention: Drug: Vyndaqel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 29, 2022
April 29, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Patients not receive Vyndaqel.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02146378
B3461042
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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