NCT00366119Unknown4 期
Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension
Pacific Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Reduction of DBP(diastolic blood pressure)
研究概览
简要总结
The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension
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
- None
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
- •mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)
排除标准
- •180mmHg≤SBP
- •If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
- •If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
- •impaired hepatic function
- •imapaired renal function
- •angioedema
- •aortic valvular stenosis or obstrcutive ejection disorder
- •primary hyperaldosteronism
- •renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis
- •severe respiratory disease
- •congestive heart failure( New York Association functional class Ⅲ or Ⅳ)
- •malignant hypertension
- •labile angina pectoris or myocardial infarction in the last 3 months before study entry
结局指标
主要结局
Reduction of DBP(diastolic blood pressure)
次要结局
- Reduction of SBP(systolic blood pressure)
- Percentage of patients with Dcrease of BP(blood pressure)
- Percentage of patients with a Normalization of BP(blood pressure)
- Artery stiffness(chang of pulse wave velocity)
- Left ventricular diastolic function
- Change of BNP
- Change of CRP
研究者
研究点 (1)
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