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

Last updated on May 11, 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.
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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Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan
Special Investigation Of Somavert -Long Term Use-
The 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.
All the patients whom an investigator prescribes the first Pegvisomant should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A6291023 prescribes the Pegvisomant.
Acromegaly
Drug: Pegvisomant

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.

Pegvisomant
Patients taking Pegvisomant.
Intervention: Drug: Pegvisomant
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
November 9, 2016
November 9, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Pegvisomant.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00658879
A6291023
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

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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Contact

[email protected]



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