Conditions: Acromegaly
Keywords: Acromegaly hormone disorder growth hormone insulin like growth factor-1 pituitary tumor pasireotide SOM230
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Detailed description:

Arms:
arm 1: Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) arm 2: Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) arm 3: If a patient is randomized to the open label arm the investigator will either:

* be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or
* continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.

Interventions: intervention 1: Pasireotide intervention 2: octreotide LAR 30mg intervention 3: lanreotide ATG 120mg
Intervention descriptions: intervention 1: * Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks intervention 2: In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization intervention 3: In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Protocol document: