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Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan

Last updated on November 15, 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.
Acromegaly
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 need to be administered Pegvisomant in order to be enrolled in the surveillance.

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

Patients not administered Pegvisomant.

NCT00658879
Pfizer
Completed
Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan

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Descriptive Information
Brief TitleLong Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Official TitleSpecial Investigation Of Somavert -Long Term Use-
Brief SummaryThe objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed DescriptionAll the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant).
ConditionAcromegaly
InterventionDrug: Somavert (Pegvisomant)

Somavert (Pegvisomant) 10, 15 or 20mg powder and solvent for solution for injection.

Dosage, Frequency : According to Japanese LPD.

Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.

Study Groups/CohortsSomavert (Pegvisomant)
Patients taking Somavert (Pegvisomant).
Intervention: Drug: Somavert (Pegvisomant)
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 StatusCompleted
Actual Enrollment
 (submitted: March 6, 2017)
251
Original Estimated Enrollment
 (submitted: April 9, 2008)
1000
Actual Study Completion DateNovember 9, 2016
Actual Primary Completion DateNovember 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Somavert (Pegvisomant).

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 NumberNCT00658879
Other Study ID NumbersA6291023
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2018

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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