Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan
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|ClinicalTrials.gov Identifier: NCT00658879|
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||251 participants|
|Official Title:||Special Investigation Of Somavert -Long Term Use-|
|Actual Study Start Date :||August 7, 2007|
|Actual Primary Completion Date :||November 9, 2016|
|Actual Study Completion Date :||November 9, 2016|
Patients taking 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.
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) [ Time Frame: 5 years ]
- Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ]
- The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ]
- This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes measures. [ Time Frame: There is no secondary outcomes for this surveillance. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658879
|Study Director:||Pfizer CT.gov Call Center||Pfizer|