Chong Kun Dang Files Phase 3 IND for Hypertension Drug CKD-339
Subsidiary Chong Kun Dang submitted IND for phase 3 trial of CKD-339 for hypertension.
Target: 300 patients with essential hypertension inadequately controlled on D107 monotherapy; multicenter, randomized, double-blind.
Primary endpoint: change in clinic MSSBP from baseline at week 10.
Trial duration: ~36 months from approval.
Statistical success rate ~10%; risk of failure or discontinuation.
KOSPI Filing Information
Filing: Major Management Matters Related To Investment Decision (Major Management Matters Of Subsidiary) (Application For Approval Of Phase 3 Clinical Trial Plan Of CKD339, A Hypertension Treatment Drug, From The Ministry Of Food And Drug Safety (MFDS))