Clinical Trial Details
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NCT01137682 : Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
PhasePhase 4
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

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

2. Patients with 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 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 is 30mg and for lanreotide ATG is 120 mg

4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been
previously submitted to surgery

Exclusion Criteria:

1. Patients who have 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 with compression of the optic chiasm causing acute clinically significant
visual field defects

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

5. Patients who have received pituitary irradiation within 10 years prior to visit 1

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

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

Other protocol-defined inclusion/exclusion criteria may apply
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