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

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)

ClinicalTrials.gov Identifier: NCT02310269

Novartis Reference Number: CSOM230B2410

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Cushings Disease
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
200 participants
Start date 
Mar 28, 2013
Completion date 
May 01, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
SOM230

Eligibility Criteria

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

Study Locations

United States
St Josephs Hospital and Medical Center
Recruiting
Phoenix, 85013
Arizona
United States
University of Southern California CSOM230B2410 - SC
Recruiting
Los Angeles, 90033
California
United States
Diabetes Research Institute SC
Withdrawn
Miami, 22136
Florida
United States
LifeBridge Heath Cardiovascular Institute, Sinai Hospital SC - SOM230B2410
Withdrawn
Baltimore, 21215
Maryland
United States
Massachusetts General Hospital SC - SOM230B2410
Recruiting
Boston, 02114
Massachusetts
United States
Ohio State University SC - SOM230B2410
Completed
Columbus, 43210
Ohio
United States
Endocrinology Services
Recruiting
Bend, 97702
Oregon
United States
Allegheny Endocrinology Associates
Recruiting
Pittsburgh, 15212
Pennsylvania
United States
R. I. Hospital Medical Oncology Clinical Research SC
Withdrawn
Providence, 02903
Rhode Island
United States
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Recruiting
Seattle, 98122-4379
Washington
United States
Canada
Novartis Investigative Site
Completed
Montreal, H2W 1T8
Quebec
Canada
Novartis Investigative Site
Completed
Sherbrooke, J1H 5N4
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4G2
-
Canada
Colombia
Novartis Investigative Site
Completed
Cali,
-
Colombia
France
Novartis Investigative Site
Completed
Amiens Cedex 1, 80054
-
France
Novartis Investigative Site
Completed
Bron Cedex, 69677
-
France
Novartis Investigative Site
Withdrawn
Dijon, 21000
-
France
Novartis Investigative Site
Completed
Lille Cedex, 59037
-
France
Novartis Investigative Site
Completed
Marseille, 13385
-
France
Novartis Investigative Site
Completed
Montpellier Cedex 5, 34295
-
France
Novartis Investigative Site
Completed
Paris, 75014
-
France
Novartis Investigative Site
Completed
Reims, 51092
-
France
Novartis Investigative Site
Completed
Saint Mande, 94160
-
France
Novartis Investigative Site
Completed
St Priest en Jarez Cedex, 42277
-
France
Novartis Investigative Site
Withdrawn
Strasbourg, 67098
-
France
Germany
Novartis Investigative Site
Withdrawn
Mannheim, 68305
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Aachen, 52074
-
Germany
Novartis Investigative Site
Withdrawn
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40225
-
Germany
Novartis Investigative Site
Completed
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Withdrawn
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Withdrawn
Frankfurt, 60596
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Halle, 06108
-
Germany
Novartis Investigative Site
Completed
Hamburg, 20246
-
Germany
Novartis Investigative Site
Withdrawn
Hamburg, 22587
-
Germany
Novartis Investigative Site
Withdrawn
Hannover, 30159
-
Germany
Novartis Investigative Site
Withdrawn
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Magdeburg, 39120
-
Germany
Novartis Investigative Site
Withdrawn
Marburg, 35039
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81667
-
Germany
Novartis Investigative Site
Withdrawn
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Oldenburg, 26122
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Israel
Novartis Investigative Site
Recruiting
Petach Tikva, 49100
-
Israel
Novartis Investigative Site
Completed
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
Recruiting
Ancona, 60126
AN
Italy
Novartis Investigative Site
Recruiting
Messina, 98125
ME
Italy
Novartis Investigative Site
Completed
Milano, 20122
MI
Italy
Novartis Investigative Site
Completed
Milano, 20149
MI
Italy
Novartis Investigative Site
Recruiting
Palermo, 90127
PA
Italy
Novartis Investigative Site
Recruiting
Padova, 35128
PD
Italy
Novartis Investigative Site
Recruiting
Pisa, 56124
PI
Italy
Novartis Investigative Site
Completed
Torino, 10126
TO
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Lebanon
Novartis Investigative Site
Completed
Ashrafieh, 166830
-
Lebanon
Netherlands
Novartis Investigative Site
Completed
Maastricht, 5800
AZ
Netherlands
Novartis Investigative Site
Completed
Nijmegen, 6500 HB
-
Netherlands
Romania
Novartis Investigative Site
Recruiting
Brasov,
-
Romania
Novartis Investigative Site
Recruiting
Bucuresti, 011863
-
Romania
Novartis Investigative Site
Recruiting
Cluj, 400006
-
Romania
Novartis Investigative Site
Recruiting
Tg. Mures, 540061
-
Romania
Sweden
Novartis Investigative Site
Withdrawn
Gothenburg, SE-413 45
-
Sweden
Novartis Investigative Site
Withdrawn
Uppsala, SE-751 85
-
Sweden
United Kingdom
Novartis Investigative Site
Completed
Plymouth, PL6 8DH
-
United Kingdom
Novartis Investigative Site
Withdrawn
Southampton, SO16 6YD
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]