Overview

This trial is active, not recruiting.

Condition acromegaly
Treatment pegvisomant
Sponsor Pfizer
Start date August 2007
End date November 2016
Trial size 200 participants
Trial identifier NCT00658879, A6291023

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients taking Pegvisomant.
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Patients need to be administered Pegvisomant in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Pegvisomant.

Additional Information

Official title Special Investigation Of Somavert -Long Term Use-
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pfizer.