Expired Study
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Philadelphia, Pennsylvania 19104


Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with Cushing's disease.


Inclusion Criteria: - Patients who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Patients who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the patient is getting significant clinical benefits from treatment with Pasireotide . - The patient did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment. - Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended Exclusion Criteria: - Patients who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or HgbA1C > 10 since starting [study CSOM230B2208] - Patients with persistent ALT/AST or alkaline phosphatase levels more than 2.5X ULN, serum creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN - Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits), WBC <3.0x1'000'000'000/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT <100x1'000'000'000/L Other protocol-defined inclusion / exclusion criteria may apply.



Primary Contact:

Study Director
Novartis Pharmaceuticlas
Novartis Pharmaceuticals

Backup Contact:


Location Contact:

Philadelphia, Pennsylvania 19104
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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