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
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
- 否
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
研究点 (23)
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