Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

Completed · Phase 2

Conditions studied: Cushing's Syndrome

In brief

Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol. Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, were not eligible for enrollment in this study. The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study was conducted in the United States and in Europe.

Key facts

Study ID

NCT02804750

Run by

Corcept Therapeutics

People needed

35

Starts

2016-06-01

Expected to finish

2018-09-01

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a confirmed diagnosis of endogenous Cushing's syndrome.
• Requires medical treatment of hypercortisolemia.
• Meets at least one of the following criteria:
• Has type 2 diabetes mellitus.
• Has impaired glucose tolerance.
• Has hypertension.

You may not qualify if…

• Has non-endogenous source of hypercortisolemia
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
• Has poorly controlled hypertension
• Has Stage ≥ 4 renal failure

Where it is running

• Study site — Laguna Hills, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Covington, Kentucky, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Richmond, Virginia, United States
• Study site — Budapest, Hungary
• Study site — Pécs, Hungary
• Study site — Cuneo, Italy
• Study site — Messina, Italy
• Study site — Milan, Italy
• Study site — Naples, Italy
• Study site — Orbassano, Italy
• Study site — Roma, Italy
• Study site — Siena, Italy
• Study site — Torino, Italy
• Study site — Leiden, Netherlands
• Study site — Rotterdam, Netherlands
• Study site — Salford, Manchester, United Kingdom

Full record on ClinicalTrials.gov

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