A Phase III multi-center double-blind randomized withdrawal study of LCI699 following a 24 week single-arm open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushings disease (PRIME)
The study aims to confirm the long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease who have had had surgery that has not been successful, or are not a good surgical candidate, or refuse surgery, and have not received radiation treatment for this condition within the past three years. . LC1699 is taken in pill form twice a day. Once eligibility has been confirmed, the study has four periods plus an optional extension period.
- Study Identifier: 820801
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