MOXONIDINE IN STAGE 1 & 2 HYPERTENSION

本研究的主要目的是根据与安慰剂相比，缓释片（SR）对1期和2期高血压患者坐位舒张压从基线到终点的变化来确定缓释片（SR）对1期和2期高血压患者的疗效。相信新的SR制剂将最大限度地减少在立即释放（IR）治疗高血压患者中观察到的嗜睡和口干的剂量限制性副作用。次要目的是确定SR莫昔定与安慰剂比较对以下方面的影响：a)坐位舒张压波谷反应率；收缩压和舒张压谷/峰比b)收缩压和舒张压c)心率d)糖化血红蛋白A1c e)脂质谱f)不良临床和实验室事件这是一项随机、安慰剂对照、双盲、多中心研究，研究对象为1期或2期原发性高血压患者。研究将包括三个阶段：(1)安慰剂导入；(2)并行主动处理；(3)冲蚀。该研究在安慰剂引入和洗脱期为单盲，在平行积极治疗期为双盲。在随机化过程中，患者将被分配四种治疗方法中的一种：莫昔定、1.5 mg、1.0 mg、0.5 mg或安慰剂。此外，仅在克利夫兰大学医院收集血浆药物水平用于药代动力学建模。

The primary objective of this study is to define the efficacy of sustained release (SR) moxonidine in Stage 1 and Stage 2 hypertensive patients based on the change from baseline to endpoint in sitting diastolic blood pressure measured at trough compared with that of placebo. It is believed that the new SR formulation will minimize the dose-limiting side effects of somnolence and dry mouth observed in immediately release (IR) treated hypertensive patients. The secondary objectives are to determine the effect of SR moxonidine compared with placebo on: a) sitting diastolic blood pressure responder rate at trough; sitting systolic and diastolic trough/peak ratios b) systolic and diastolic blood pressures c) heart rate d) glycosylated hemoglobiin A1c e) lipid profile f) adverse clinical and laboratory events This is a randomized, placebo-controlled, double-blind, multicenter study in patients with Stage 1 or Stage 2 essential hypertension. The study will consist of three periods: (1) placebo lead-in; (2) parallel active treatment; and (3) washout. The study is single-blind during the placebo lead-in and washout periods and double-blind during the parallel active treatment period. During randomization patients will be assigned one of four treatments: moxonidine, 1.5 mg, 1.0 mg 0.5 mg or placebo. Additionally, plasma drug levels will be collected for pharmacokinetic modeling at the University Hospitals of Cleveland site only.