Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo
 after a single injection. Effectiveness and safety were then also assessed following four
 fixed-dose injections and after one year of treatment given at titrated doses.
Inclusion Criteria:

 -  documentation of a diagnosis of active acromegaly based on either of the following
 definitions:

 1. the patient has never received somatostatin analog nor dopaminergic agonist or
 had previously received this medication but had stopped more than 3 months before
 visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or

 2. the patient was receiving treatment with a somatostatin analog (other than
 lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL
 at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels
 between visit 1 and visit 2 (or visit 2a)

 Exclusion Criteria:

 -  receipt of radiotherapy for acromegaly within 3 years

 -  pituitary surgery within 3 months prior to visit 1

 -  prior receipt of lanreotide autogel or GH antagonist

 -  anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study
 period

 -  known hypersensitivity to any of the test materials or related compounds

 -  clinically significant renal or hepatic abnormalities