[Edaily Reporter NA EUN-KYUNG ] CHONGKUNDANG(185750)’s hypertension treatment candidate “CKD-339,” currently under development, is set to enter Phase 3 clinical trials in South Korea.
CHONGKUNDANG HOLDINGS CORP. announced on the 27th that its subsidiary, CHONGKUNDANG, had received approval from the Ministry of Food and Drug Safety for the Phase 3 clinical trial plan (IND) for CKD-339 in South Korea.
This clinical trial will be conducted to compare the efficacy and safety of a D107 monotherapy group with a group receiving D107 in combination with either D211 or D311 in patients with essential hypertension whose blood pressure is not adequately controlled with D107 monotherapy. The primary efficacy endpoint is the change in mean sitting systolic blood pressure (MSSBP) at 10 weeks compared to baseline.
The clinical trial will be conducted as a multicenter, randomized, double-blind study involving 300 patients in South Korea. The trial duration is approximately 36 months from the date of approval by the Ministry of Food and Drug Safety (MFDS) and may vary depending on the rate of subject enrollment.
CKD-339 is a candidate drug currently under development to evaluate the efficacy and safety of combination therapy in patients with essential hypertension whose blood pressure is not adequately controlled with D107 monotherapy. CHONGKUNDANG plans to confirm the efficacy and safety of CKD-339 through this clinical trial.
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