CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 251 enrolled
Drug / intervention
Somavert (Pegvisomant)drug
Likely dose
Somavert (Pegvisomant) 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00658879
NCT00658879N/ACompleted
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SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE-

Pfizer·observational·Posted Apr 15, 2008·Updated Sep 25, 2023

In Brief

An observational study evaluating Somavert (Pegvisomant) for Acromegaly. Completed, enrolled 251 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2008
Enrollment StartAug 7, 2007
Primary CompletionNov 9, 2016
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 18.2 years ago

Interventions

Somavert (Pegvisomant)drug

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.