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
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
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose
 monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone
 antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth
 factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at
 conventional regimen.
Inclusion Criteria:

 • Patient with a biochemically documented active acromegaly, not adequately controlled by
 somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and
 elevated IGF-1 (adjusted for age and gender)

 -  Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25%
 from any medical pretreatment level

 -  Patient currently receiving somatostatin-analogues at conventional regimen (maximum
 registered dose) for at least 6 months before inclusion

 Exclusion Criteria:

 -  Newly diagnosed or previously medically untreated acromegalic patient

 -  Concomitant treatment with GH-receptor antagonist

 -  Concomitant treatment with dopamine-agonist

 -  Symptomatic cholelithiasis or choledocolithiasis

 -  Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according
 to local laboratory)

 -  Previous gamma-knife radiotherapy for treatment of acromegaly

 -  Compression of the optic chiasm causing visual field defect

 -  Any medical conditions contraindicated in the Summary of Product Characteristic (SPC)
 of all drugs

 Other protocol-defined inclusion/exclusion criteria may apply