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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00434148 |
This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.
Condition | Intervention | Phase |
---|---|---|
Cushing's Disease |
Drug: Pasireotide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 162 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
600ug b.i.d: Experimental | Drug: Pasireotide |
900ug b.i.d: Experimental | Drug: Pasireotide |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Stanford Cancer Center | |
Stanford, California, United States, 94305 | |
UCLA Med-Endo | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Denver Research Institute - VA Medical Center | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
University of Florida - Division of Endocrinology | |
Gainesville, Florida, United States, 32610 | |
United States, Illinois | |
University Chicago Hospital | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Mass General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Columbia Presbyterian Hospital | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cleveland Clinic, Endocrine & Metabolic Institute | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health and Sciences University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390-8857 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Seattle Neuroscience Specialists | |
Seattle, Washington, United States, 98122 | |
VA Puget Sound Health Care System | |
Tacoma, Washington, United States, 98493 | |
United States, Wisconsin | |
Midwest Endocrinology Associates, St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States, 53215 | |
Canada, British Columbia | |
Novartis Investigative Site | |
Vancouver, British Columbia, Canada | |
Canada, Nova Scotia | |
Novartis Investigative Site | |
Halifax, Nova Scotia, Canada |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSOM230B2305 |
Study First Received: | February 9, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00434148 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Brazil: National Health Surveillance Agency; Canada: Health Canada; China: Ministry of Health; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: German Institute of Medical Documentation and Information; Greece: National Organization of Medicines; Italy: The Italian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Spain: Ministry of Health and Consumption; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Cushing's Disease pasireotide SOM230 |
Hypothalamic Diseases Pituitary ACTH Hypersecretion Pituitary Diseases Cushing Syndrome Central Nervous System Diseases Endocrine System Diseases |
Adrenal Gland Diseases Endocrinopathy Brain Diseases Adrenocortical Hyperfunction Recurrence |
Hypothalamic Diseases Pituitary ACTH Hypersecretion Hyperpituitarism Pituitary Diseases Nervous System Diseases Cushing Syndrome |
Central Nervous System Diseases Endocrine System Diseases Adrenal Gland Diseases Brain Diseases Adrenocortical Hyperfunction |