[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of WS016 in the treatment of patients with hyperkalemia
Part A:主要目的: 评估起始2天纠正高血钾治疗后血钾达标的受试者中,不同剂量的WS016,每日一次口服给药,连续给药28天,维持血钾在正常范围内(血钾:3.5 – 5.0 mmol/L,包括边界值)的有效性和安全性。
次要目的:评估WS016纠正高血钾起始治疗2天的有效性与安全性;评估WS016对其它电解质的影响。
Part B:主要目的:评估扩展阶段WS016的长期安全性。次要目的:评估扩展阶段WS016的长期有效性。
[Translation] Part A: Primary objective: To evaluate the efficacy and safety of different doses of WS016, administered orally once daily for 28 consecutive days, in subjects whose blood potassium reaches the target after the initial 2 days of hyperkalemia correction, to maintain blood potassium within the normal range (blood potassium: 3.5 – 5.0 mmol/L, including the boundary value).
Secondary objective: To evaluate the efficacy and safety of WS016 in the initial 2-day treatment of hyperkalemia correction; to evaluate the effect of WS016 on other electrolytes.
Part B: Primary objective: To evaluate the long-term safety of WS016 in the extended phase. Secondary objective: To evaluate the long-term effectiveness of WS016 in the extended phase.