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PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WI...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000155-34

PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA

Femme et Homme

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Extrait

To evaluate the efficacy of Lanreotide Autogel 120 mg when used as primary medical treatment in untreated de novo acromegalic patients with macroadenoma, as assessed by evaluating the change in pituitary tumor volume at Week 48 (after 12 injection – V5) compared to baseline volume (V1). A 20% reduction from baseline (as measured by MRI at V1) will be considered to be clinically significant.

Critère d'inclusion

  • ACROMEGALY ASSOCIATED WITH PITUITARY GLAND MACROADENOMA

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