Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
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.
Inclusion Criteria:

 1. Patients with written informed consent prior to any study related activity

 2. Patients who had inadequately controlled acromegaly as defined by a mean GH
 concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and
 age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)

 3. Patients who had been treated with maximum indicated doses of octreotide LAR or
 lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum
 indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg

 4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have
 been previously submitted to surgery

 5. Patients who completed the 24-week treatment period in core according to the
 requirements of the core study protocol or corresponding amendments could enter
 extension

 Exclusion Criteria:

 1. Patients who had received pasireotide (SOM 230) prior to enrolment

 2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine
 agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1
 (screening)(8 weeks wash out period). Such patients must have been treated with
 octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum
 of 6 months prior to starting combination therapy and they should have been
 inadequately controlled on monotherapy.

 3. Patients who had compression of the optic chiasm causing acute clinically significant
 visual field defects

 4. Patients who required a surgical intervention for relief of any sign or symptom
 associated with tumor compression

 5. Patients who had received pituitary irradiation within 10 years prior to visit 1
 (screening).

 6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks
 prior to visit 1 (screening).

 7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid
 hormone replacement therapy