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Clinical Trials associated with KDF1901A Randomized, Double-Blind, Multi-Center, Phase III Trial to Evaluate the Efficacy and Safety of KDF1901 in Patients With Essential Hypertension Inappropriately Controlled on KDF1901-R0 Treatment
This randomized, double-blind, multicenter phase 3 clinical trial evaluated the efficacy and safety of KDF1901, a single-pill triple combination of valsartan, amlodipine, and chlorthalidone, in patients with essential hypertension inadequately controlled with dual therapy. A total of 286 patients who remained uncontrolled after a 4-week run-in period with valsartan/amlodipine were randomized to receive either KDF1901 (valsartan/amlodipine/chlorthalidone 160/10/25 mg) or a dual combination of valsartan/amlodipine (160/10 mg) for 8 weeks.
The primary endpoint was the change in mean sitting systolic blood pressure (MSSBP) from baseline at week 8. Secondary outcomes included changes in diastolic BP (MSDBP), blood pressure normalization rate, and response rate. KDF1901 demonstrated significantly greater reductions in both MSSBP and MSDBP, with higher normalization and response rates compared to dual therapy. The treatment was well tolerated, and the incidence of adverse events was comparable between groups.
100 Clinical Results associated with KDF1901
100 Translational Medicine associated with KDF1901
100 Patents (Medical) associated with KDF1901
100 Deals associated with KDF1901