A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Inclusion Criteria

Inclusion criteria:

- Patients with active acromegaly (based on elevated GH and IGF-1 levels)

- Patients who have undergone one or more pituitary surgeries, but have not been
treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI
and who refuse pituitary surgery or for whom pituitary surgery is contraindicated

- Patients for whom written informed consent to participate in the study has been
obtained prior to any study related activity

Exclusion criteria:

- Patients who are being or were treated with octreotide, lanreotide, dopamine agonists
or GH antagonists with the exception of a single dose of short-acting octrotide or
short-acting dopamine agonists. In case of a single dose of short-acting octrotide,
the dose should not be used to predict the response to the octretide treatment. The
single dose of short-acting octreotide or short-acting dopamine agonists should not
be administered in the 3 days prior to randomization

- Patients with compression of the optic chiasm causing any visual field defect

- Patients who have received pituitary irradiation within the last ten years prior to
visit 1

- Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply