Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Status:	Recruiting
Conditions:	Endocrine
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - Any
Updated:	8/22/2018
Start Date:	March 28, 2013
End Date:	September 27, 2023
Contact:	Novartis Pharmaceuticals
Phone:	1-888-669-6682

Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

This is a non-interventional, multinational, multi-center post-marketing study, to further
document the safety and efficacy of pasireotide s.c. administered in routine clinical
practice in patients with Cushing's disease. Patients with Cushing's disease and treated with
pasireotide s.c. alone and in combination with other therapies will be monitored. For this
study, each enrolled patient will be followed up for 3 years after enrollment. Patients who
permanently discontinue pasireotide s.c. prior to completing the 3-year observation period
will be followed up for 3 months after the last dose of pasireotide s.c.

Inclusion Criteria:

- Male or female patients aged 18 years or older with a diagnosis of Cushing's disease
for whom surgery has failed or for whom surgery is not an option

- Patients must be treated with pasireotide s.c. started either at the first visit for
this study or prior to study entry

Exclusion Criteria:

- Patients with ectopic ACTH-dependent Cushing's syndrome

- Patients with adrenal Cushing's syndrome

- Patients with Pseudo Cushing's syndrome

We found this trial at

sites

Ohio State University SC - SOM230B2410

Columbus, Ohio 43210

Principal Investigator: Lawrence Kirschner

Phone: 614-688-6885

from

Columbus, OH