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.
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
10
sites
Seattle, Washington
Principal Investigator: Zachary Litvak
Phone: 206-320-7115
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Baltimore, Maryland 21215
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Bend, Oregon 97702
Principal Investigator: Travis Monchamp
Phone: +1 641 317 5600 x63194
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Boston, Massachusetts 02114
Principal Investigator: Nicholas Tritos
Phone: 617-726-7473
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Columbus, Ohio 43210
Principal Investigator: Lawrence Kirschner
Phone: 614-688-6885
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Los Angeles, California 90033
Principal Investigator: John Carmichael
Phone: 323-442-7544
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Murray B Gordon
Phone: 412-359-5143
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Providence, Rhode Island 02903
Principal Investigator: Geetha Gopalakrishnan
Phone: 401-444-2091
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