A prospective single-centre double blind randomized study on the efficacy and safety of 4 weekly pasireotide LAR administration in combination with or without weekly pegvisomant in previously controlled acromegaly subjects with combined treatment of long-acting somatostatin analogs and weekly pegvisomant.

INTERVENTION: Trade Name: Signifor Product Name: Pasireotide LAR Product Code: SOM230 LAR Pharmaceutical Form: Suspension for injection in pre‐filled syringe CONDITION: Acromegaly Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: Main Objective: The primary study objective is to assess the percentage of patients who remain within the IGF‐I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment.; Primary end point(s): The main study endpoints are the proportion of patients who respond (defined as normalization of IGF‐I levels within the age adjusted normal limits) after 24 weeks in the pasireotide LAR monotherapy group and the pasireotide LAR in combination with pegvisomant group. Secondary Objective: To assess the percentage of patients who remain within the IGF‐I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG‐V in patients with an IGF‐I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG‐V, after 48 weeks of treatment (V8).; ; Safety will be assessed based on: adverse events, clinical examination, vital signs, glucose tolerance, EKG, standard hematology, biochemistry, endocrine function tests, GH, PEG‐V levels and liver function tests. Timepoint(s) of evaluation of this end point: 24 weeks SECONDARY OUTCOME: Secondary end point(s): To assess the number of patients who remain within the IGF‐I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG‐V in patients with an IGF‐I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG‐V, after 48 weeks of treatment (V8).; The proportion of patients who respond will be calculated along with the exact binomial two‐sided 95% confidence interval in each treatment arm. The analysis will be based on the full analysis set.; Timepoint(s) of evaluation of this end point: 48 weeks INCLUSION CRITERIA: A written informed consent. Male or female age = 18 years. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF‐I levels. The patient is treated with lanreotide Autosolution or octreotide LAR for at least 6 months and has a serum IGF‐I level above the 60th percentile and below 1.2 x ULN, 28 days after the last injection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30