Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Completed · Phase 3

Conditions studied: Cushing's Disease

In brief

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.

Key facts

Study ID

NCT00434148

Run by

Novartis Pharmaceuticals

People needed

162

Starts

2006-12-01

Expected to finish

2014-05-01

Last updated by the study team

2016-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or greater
• Confirmed diagnosis of ACTH-dependent Cushing's disease
• Not considered candidate for pituitary surgery

You may not qualify if…

• 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 apply.

Where it is running

• University Chicago Hospital Dept. of Univ of Chicago — Chicago, Illinois, United States
• Dana Farber Cancer Institute The Melanoma Program — Boston, Massachusetts, United States
• Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed — New York, New York, United States
• Cleveland Clinic Foundation Dept. of Cleveland Clinic (6) — Cleveland, Ohio, United States
• Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU. — Portland, Oregon, United States
• University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr. — Dallas, Texas, United States
• University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8) — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Swedish Medical Center Dept.ofSeattle Neuroscience(2) — Seattle, Washington, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Curitiba, Paraná, Brazil
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Ribeirão Preto, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Halifax, Nova Scotia, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Beijing, Beijing Municipality, China
• Stanford University Medical Center Stanford Cancer Center (3) — Stanford, California, United States

Full record on ClinicalTrials.gov

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