Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
Status:
Completed
Trial end date:
2018-09-27
Target enrollment:
Participant gender:
Summary
This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and
safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly
with maximal approved doses of first generation somatostatin analogues. The study will enroll
inadequately controlled patients by high doses (maximal approved) of first-generation
somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40
mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of
core phase and have completed all the assessments at the core phase completion visit can move
into the 32-week extension phase. Patients can continue with study treatment until
pasireotide LAR is commercially available and reimbursed in their respective country or until
the end of the extension phase whichever occurs first.