An Open Label Study to Assess the Safety and Efficacy of COR-003(2S 4R-Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
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- STATUS
- Recruiting
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- participants needed
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Summary
The purpose of this clinical research study is to find out if the drug COR-003 is safe and has beneficial effects in patients who have Cushings disease and to determine the most effective dosage for each individual subject. . COR-003 is taken in pill form twice a day. The study will involve 90 people with Cushings disease in North America and in certain European countries. The study will begin with a screening period followed by a dose finding phase, lasting 2-16 weeks, to determine the most effective and tolerable maximum dose for an individual subject. Once the appropriate dose has been determined, subjects will take the study medicine for 6 months. At the end of six months, subjects will be followed for another 6 months so that more information can be collected.
Details
| Condition | Cushing syndrome |
|---|---|
| Age | 1years - 99years |
| Clinical Study Identifier | 819642 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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