A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
研究概览
简要总结
The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)
- •Aged at least 18 years old
- •Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent
排除标准
- •Subjects who were already on beta-blocker therapy at the time of recruitment
- •Subjects with heart rate of at most 60 beats per minute (bpm) at rest
- •Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
- •Subjects with coronary conduction disorders (bundle branch block)
- •Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
- •Subjects who are pregnant or expect to be pregnant within the 24-week study period
- •Subjects on oral contraceptives
- •Subjects with asthma or a history of asthma
- •Subjects with documented severe renal disease
- •Subjects on anti-neoplastic drugs
研究组 & 干预措施
Bisoprolol
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
时间窗: Baseline, Week 12
The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.
Percentage of Participants With Controlled BP
时间窗: Week 12
Controlled BP was defined as BP less than 130/80 mmHg.
Percentage of Participants With Response to Study Drug
时间窗: Week 12
Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
时间窗: Week 12
Mean Change From Baseline in Heart Rate at Week 12
时间窗: Baseline, Week 12
The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.
次要结局
- Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12(Week 12)
- Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12(Baseline, Week 12)
- Mean Change From Baseline in HbA1c at Week 12(Baseline, Week 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 12)
- Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12(Week 12)
- Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12(Baseline, Week 12)