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

NCT00658879 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 251

Last updated 2023-09-25

Study results available
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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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-07
Primary Completion
2016-11-09
Completion
2016-11-09

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658879 on ClinicalTrials.gov