NCT00424541已完成1 期
A Multiple Center, Randomized, Double Blind, Parallel Group, Multiple Oral Doses Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profiles of 150 mg and 300 mg of SPP100 in Japanese Patients With Mild to Moderate Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28
研究概览
简要总结
This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.
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
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with mild to moderate essential hypertension aged 20 to 80 years
- •Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:
- •14 days before treatment: ≥ 90 mmHg and < 110 mmHg
- •3 days before treatment: ≥ 95 mmHg and < 110 mmHg
- •The difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmHg
- •Body weight no less than 50 kg
排除标准
- •Patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmHg and/or mean diastolic blood pressure ≥ 110 mmHg at Day -28, Day -14 and Day -
- •Patients with or suspected of having secondary hypertension
- •Patients suspected of having malignant hypertension
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28
次要结局
- safety
- effect of aliskiren on the RAS profile
- relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren
研究者
研究点 (2)
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