A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

Inclusion Criteria:

- Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able
to care for most of their personal needs)

- For patients on medical treatment for Cushing's disease the following washout periods
must be completed before screening assessments are performed

- Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week

- Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and
PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks

- Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks

- Octreotide (immediate release formulation): 1 week

Exclusion Criteria:

- Patients who are considered candidates for surgical treatment at the time of study
entry

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

- Patients who have had any previous pasireotide treatment

- Patients who have been treated with mitotane during the last 6 months prior to Visit
1

- Diabetic patients on antihyperglycemic medications with poor glycemic control as
evidenced by HbA1c >8%

- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT
syndrome, or concomitant medications known to prolong QT interval

- Female patients who are pregnant or lactating, or are of childbearing potential
(defined as all women physiologically capable of becoming pregnant) and not
practicing an effective method of contraception/birth control. Sexually active males
must use a condom during intercourse while taking the drug and for 2 months after the
last dose of study drug and should not father a child in this period. A condom is
required to be used also by vasectomized men in order to prevent delivery of the drug
via seminal fluid