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 (HOSCAR)

NCT01278342 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	COMPLETED
Enrolment	70
Start date	2006-09
Completion	2009-11

Conditions

• Acromegaly

Interventions

• Sandostatin LAR
• pegvisomant
• cabergoline

Primary outcomes

• The Percentage of Participants With Complete Response (CR) at 8 Months — From Baseline to 8 months
  A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment: * Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and * IGF-I within the Central Laboratory Normal Range (for age and gender).

Countries

France, Italy, Poland, Portugal, Switzerland