NCT00933920已完成1 期
A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.
研究概览
简要总结
The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
- •Patients who are eligible and able to participate in the study
- •Exclusion criteria:
- •Severe hypertension
- •Secondary form of hypertension.
- •Type 1 or type 2 diabetes mellitus
- •Serum potassium out side laboratory reference range
- •Any history of hypertensive encephalopathy or cerebrovascular accident
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Fed Group
Active Comparator
干预措施: Aliskiren (Drug)
Fasted group
Active Comparator
干预措施: Aliskiren (Drug)
结局指标
主要结局
Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.
时间窗: 28 Days
次要结局
- Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal(28 Days)
- Assess safety and tolerability of aliskiren when given with and without light meal(28 days)
- Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal(28 days)
研究者
研究点 (2)
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