A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) sc Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease
18 Years
N/A
Both
Cushing's Disease
Trial Information
A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) sc Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Inclusion Criteria
Inclusion criteria
- 18 years or greater
- Confirmed diagnosis of ACTH-dependent Cushing's disease
- Not considered candidate for pituitary surgery
Exclusion criteria
- History of pituitary irradiation in the last 10 years
- Cushing's syndrome not caused by pituitary tumor
- Patients with active malignant disease (cancer) in the last 5 years
- Women who are pregnant or lactating
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group
Outcome Description:
A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSOM230B2305
NCT ID:
NCT00434148
Start Date:
December 2006
Completion Date:
June 2013
Related Keywords:
- Cushing's Disease
- Cushing's Disease
- pasireotide
- SOM230
- Cushing Syndrome
- Pituitary ACTH Hypersecretion
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU. | Portland, Oregon 97239 |
| Stanford University Medical Center Stanford Cancer Center (3) | Stanford, California 94304 |
| University Chicago Hospital Dept. of Univ of Chicago | Chicago, Illinois 60637 |
| Dana Farber Cancer Institute The Melanoma Program | Boston, Massachusetts 02115 |
| Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed | New York, New York 10032 |
| Cleveland Clinic Foundation Dept. of Cleveland Clinic (6) | Cleveland, Ohio 44195 |
| University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr. | Dallas, Texas 75390-8527 |
| MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(8) | Houston, Texas 77030-4009 |
| Swedish Medical Center Dept.ofSeattle Neuroscience(2) | Seattle, Washington |
