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

Phase 4 Completed 70 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2006-09
Primary completion: 2009-11
Completion: 2009-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabergoline	Small molecule	0.5 mg	—
Subject	Octreotide	Peptide	40 mg	Intramuscular
Subject	Pegvisomant	Protein / enzyme biologic	70 mg	Subcutaneous

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

Summary

Timeline

Drugs

Indications