欧洲治疗高血压用药物临床研究指导原则

European Guidance on Clinical Investigation of Medicinal Products for the Treatment of Hypertension

本指导原则旨在为评价治疗高血压的药物提供依据。本指导原则包括高血压诊断标准、评价疗效的标准（血压、发病率及死亡率、靶器官损伤）、评价疗效的方法、病人选择、试验设计、安全性评价及有关固定组合用药。

These notes are intended to provide guidance for the evaluation of drugs in thetreatment of hypertension. They embrace standard diagnosis of hypertension, assessmentof efficacy criteria (including blood pressure, morbidity and mortality, target organ damage),methods to assess efficacy, selection of patients, strategy design, safety aspects and relativefixed combinations.