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临床试验/NCT02242825
NCT02242825已完成不适用

Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

Boehringer Ingelheim0 个研究点目标入组 8,148 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
8,148
主要终点
Change from Baseline in systolic blood pressure (SBP)

研究概览

简要总结

The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

排除标准

  • Age < 18 years

研究组 & 干预措施

Patients with hypertension and diabetes mellitus

干预措施: MicardisPlus® (Drug)

Patients with hypertension and diabetes mellitus

干预措施: Micardis® (Drug)

结局指标

主要结局

Change from Baseline in systolic blood pressure (SBP)

时间窗: Baseline, after 6 months

Change from Baseline in diastolic blood pressure (DBP)

时间窗: Baseline, afterr 6 months

次要结局

  • Assessment of metabolic effect on a 4-point scale(after 6 months)
  • Assessment of efficacy by investigator on a 6-point scale(after 6 months)
  • Assessment of tolerability by investigator on a 5-point scale(after 6 months)
  • Change from Baseline in laboratory parameters(Baseline, after 6 months)
  • Number of patients with adverse events(up to 6 months)

研究者

申办方类型
Industry
责任方
Sponsor

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