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临床试验/NCT02298556
NCT02298556已完成不适用

A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus

Abbott23 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Abbott
入组人数
270
试验地点
23
主要终点
Absolute change in systolic blood pressure

研究概览

简要总结

To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Male or female
  • ≥ 18 years old
  • Has been already diagnosed with hypertension
  • Has been already diagnosed with type 2 diabetes mellitus
  • Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment
  • Heart rate ≥70 beat per minute

排除标准

  • Pregnant or breast feeding female
  • Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
  • Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;
  • Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
  • Is currently participating in another clinical or non-clinical study

结局指标

主要结局

Absolute change in systolic blood pressure

时间窗: from baseline to week 8

mmHg

次要结局

  • Absolute change in diastolic blood pressure (DBP)(from baseline to week 8)
  • Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg(from baseline to week 8)
  • Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)(from baseline to week 8)
  • Absolute change of heart rate(from baseline to week 8)
  • Correlation between absolute change in blood pressure and absolute change in heart rate(from baseline to week 8)
  • The absolute change in PR interval on electrocardiography(from baseline to week 8)
  • The absolute change in HbA1c (if available)(from baseline to week 8)
  • The absolute change in microalbuminuria (if available)(from baseline to week 8)
  • The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event(from baseline to week 8)
  • The correlation between physician's office and home blood pressure measurements (Difference in medians)(from baseline to week 8)
  • Blood pressure variability (daily or hourly) in home blood pressure measurement(from baseline to week 8)

研究者

发起方
Abbott
申办方类型
Industry
责任方
Sponsor

研究点 (23)

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