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Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Last updated on October 17, 2019

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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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Descriptive Information
Brief TitleVyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleVYNDAQEL DRUG USE INVESTIGATION (REGULATORY POST MARKETING COMMITMENT PLAN)
Brief SummaryThe 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 DescriptionBoth prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Other
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe subjects of this surveillance are all patients who received Vyndaqel.
ConditionTransthyretin Familial Amyloid Poluneuropathy
InterventionDrug: Vyndaqel
20mg/day
Study Groups/CohortsVyndaqel
Intervention: Drug: Vyndaqel
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 StatusActive, not recruiting
Estimated Enrollment
 (submitted: May 21, 2014)
200
Original Estimated EnrollmentSame as current
Estimated Study Completion DateApril 11, 2022
Estimated Primary Completion DateApril 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02146378
Other Study ID NumbersB3461042
Has Data Monitoring CommitteeNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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