drugset / Trial / NCT00383708

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

NCT00383708

Phase 3 Completed 125 enrolled Ipsen
NaSingle-groupOpen-labelTreatment

Summary

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Timeline

Start
2006-10
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanreotide Other / unclassified 120 mg Subcutaneous
Subject Pegvisomant Protein / enzyme biologic 40 mg Subcutaneous
Subject Pegvisomant Protein / enzyme biologic 120 mg Subcutaneous

Indications