NL-OMON41645已完成不适用
Pharmacokinetic and pharmacodynamic properties of amlodipine oral liquid in the pediatric population - PK-PD of amlodipine in children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Age between 6 months and 12 years, signed consent from the parent or legal assent, ongoing treatment with amlodipine at the same dosage for at least 2 weeks, no anticipated change in use of amlodipine or other antihypertensive medication
排除标准
- •Concomitant treatment with another investigational drug within 1 month prior to study entry, transient, unstable, malignant, or accelerated hypertension, poor vascular access, history of noncompliance, allergy to one of the compounds of the investigational product, or one of the contraindications of amlodipine use (hypersensitivity to dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction), renal transplant within 4 months before inclusion.
研究者
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