NCT00649311终止2 期
Clinical Protocol For A Double-Blind, Randomized, Active- Controlled Comparison Study Of The Antihypertensive Effect Of Eplerenone Versus Losartan In Patients With Mild To Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8
研究概览
简要总结
The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
详细描述
This Phase 2 study EPLA-0501-072 (A6141012) was conducted beginning 02 April 2003 and was prematurely terminated due to poor enrollment on 12 September 2003. There were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. There were no serious adverse events or deaths reported during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and <110 mmHg and seSBP <180 mmHg
- •Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period
排除标准
- •Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension
- •The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit
研究组 & 干预措施
Eplerenone group
Experimental
干预措施: eplerenone (Drug)
Losartan group
Active Comparator
干预措施: Losartan (Drug)
结局指标
主要结局
Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8
时间窗: 8 weeks
次要结局
- Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8(8 weeks)
- Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP(8 weeks)
- Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events(8 weeks)
研究者
研究点 (1)
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