A Phase III, multicenter, double-blind, randomized withdrawal study of LCI699 to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.
| Title | A Phase III, multicenter, double-blind, randomized withdrawal study of LCI699 to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease. |
|---|---|
| Description | A Phase III, multicenter, 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 Cushing's disease. Objective: The primary objective was to compare the complete response rate at the end of the 8-week period of randomization withdrawal (Week 34) between patients randomized to continued osilodrostat therapy vs. placebo. |
| Organism | Homo sapiens |
| Data Type | Other Type of Metabolome Data |
| Data Accessibility | Controlled-access |
| BioProject | PRJCA015653 |
| Release Date | 2023-04-13 |
| Submitter | Xiao Hui Guo (bdyyguoxiaohui@sina.com) |
| Organization | Peking University First Hospital |
| Submission Date | 2023-03-20 |
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| File ID | File Title | Number/Samples | File Type | File Size | File Suffix | Download Times | Download |
|---|---|---|---|---|---|---|---|
| OMIX003410-02 | pk data of 4 Chinese patients of LCI699C2301 | 4 | Other Type of Metabolome Data | 61.0 KB | xlsx | 0 | Controlled |