An Open Label Study to Assess the Safety and Efficacy of COR-003(2S 4R-Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
Brief Description Of Study
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.