A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently
To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains Mean Urinary Free Cortisol (mUFC) ≤ 1.0 X Upper Limit of Normal (ULN) at month 7 regardless of dose-titration.
7 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CSOM230G2304
NCT01374906
August 2011
August 2016
Name | Location |
---|---|
Stanford University Medical Center SC | Stanford, California 94304 |
Cleveland Clinic Foundation CCF - Euclid Loc | Cleveland, Ohio 44195 |
University of Pennsylvania - Clinical Studies Unit Unniv SC | Philadelphia, Pennsylvania 19104 |
University of Texas Southwestern Medical Center UT southwest | Dallas, Texas 75390-8527 |
Swedish Medical Center Swedish | Seattle, Washington |
Medical College of Wisconsin MCW 2 | Milwaukee, Wisconsin 53226 |
ClinTriCo | Phoenix, Arizona 85083 |
University of California at Los Angeles UCLA Tiverton | Los Angeles, California 90095 |
John Wayne Cancer Center | Santa Monica, California 90404 |
Harbor-UCLA Medical Center LA Biomed | Torrance, California 90509 |
Emory University School of Medicine/Winship Cancer Institute G2304 | Atlanta, Georgia 30322 |
Pituitary Center, Division of Endocrinology SC | Baltimore, Maryland 21287 |
University of Michigan Comprehensive Cancer Center SC-2 | Ann Arbor, Michigan 48109-0944 |
Mount Sinai School of Medicine Mt. Sinai Medical Center | New York, New York 10029 |
Oregon Health & Sciences University DeptofOregonHealth&Sciences(2) | Portland, Oregon 97201 |