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A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurre...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004111-22

A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease

Femme et Homme

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Extrait

To assess the efficacy in terms of response to pasireotide 600 μg s.c. b.i.d. and 900 μg s.c. b.i.d. independently in patients with Cushing’s disease as measured by UFC ≤1.0 X ULN from baseline after 6 months of treatment

Critère d'inclusion

  • Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females

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