Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan
|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|
|Primary Completion Date :||November 9, 2016|
|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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658879
|Study Director:||Pfizer CT.gov Call Center||Pfizer|