Accession |
PRJCA015653 |
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. |
Relevance |
Medical |
Data types |
PK analysis
|
Organisms |
Homo sapiens
|
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. |
Sample scope |
PK analysis sample |
Release date |
2023-04-16 |
Grants |
Agency |
program |
Grant ID |
Grant title |
No funding support
|
|
|
|
|
Submitter |
Xiao Hui
Guo (bdyyguoxiaohui@sina.com)
|
Organization |
Peking University First Hospital |
Submission date |
2023-03-19 |