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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cushing's Disease

Thank you

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 MedicineHouston, 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 ChicagoChicago, Illinois  60637
Dana Farber Cancer Institute The Melanoma ProgramBoston, Massachusetts  02115
Columbia University Medical Center- New York Presbyterian Columbia University DeptofMedNew 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