An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen

Registry ID
EUCTR2005-005852-42
Source registry
EUCTR
Status
Completed
Phase
PHASE3
Sponsor
NOVARTIS FARMA
Start date
2007-04-20
Completion date
2010-01-28
Last update
2026-08-16

Conditions

Summary

The primary objective of this study is to investigate the efficacy of 8-months treatment of Sandostatin LAR High Dose monotherapy or Sandostatin LAR High Dose in combination either with GH antagonist or dopamine agonist to control both biochemical parameters GH and IGF-I in a large population of acromegalic patients not achieving biochemical normalization after at least 6 months of SSA at conventional regimen. For the purpose of this study, the definition of SSA at conventional regimen is Sandostatin LAR octreotide at 30 mg every 28 days - Autogel lanreotide at 120 mg every 28 days.

Locations

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