CKD-339, an essential hypertension treatment under development by Chong Kun Dang, is advancing into a Phase 3 clinical trial in South Korea.
Chong Kun Dang received approval on the 27th from the Ministry of Food and Drug Safety (MFDS) for its Phase 3 clinical trial plan for CKD-339, according to regulatory filings on the 28th. The company originally submitted its trial application to the MFDS on May 14.
The study will enroll patients with essential hypertension whose blood pressure remains inadequately controlled on D107 monotherapy. The trial is designed to compare the therapeutic efficacy and safety of D107 monotherapy against two combination regimens pairing D107 with either D211 or D311.
The primary efficacy endpoint is the change from baseline in mean sitting systolic blood pressure measured in a clinic setting (clinic MSSBP) following 10 weeks of treatment.
The Phase 3 trial will be conducted across 300 patients in South Korea as a randomized, double-blind, multicenter, therapeutic confirmatory study. The anticipated study duration is approximately 36 months from the date of MFDS approval, though the final timeline may shift depending on patient recruitment rates.
