Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- To assess the changes of pulse pressure at 12 weeks
研究概览
简要总结
The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive patients with metabolic syndrome
-Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure produced one heart beat.
详细描述
Primary Objective
-To assess the changes of pulse pressure at 12 weeks
Secondary Objectives
-
To assess the changes of pulse pressure at 4, 24 weeks
-
To assess the changes of systolic blood pressure and diastolic blood pressure at each visit
-
Percentage of responder rate* at each visit and time to get normalized BP from enrollment
-
Responder rate at last visit
-
To assess IIEF-5 (5-item Version of the International Index of Erectile Function) score at enrollment and 24 weeks (percentage of patients with ED according to IIEF-5, Changes of IIEF-5 domains)
-
Percentage of patients with erectile dysfunction (ED) according to IIEF-5 and changes of PP in subgroup (age 65, body mass index (BMI) 23, diabetes mellitus, dyslipidemia, benign prostate hypertrophy)
-
Analysis of correlation between ED and concomitant disease and concomitant medications in patients who received Eprosartan
-
Score changes of Framingham 10-year Coronary Heart Disease (CHD) risk at 1st visit, 4th visit
-
Percentages of Eprosartan monotherapy and multiple antihypertensive therapies at enrollment and last visit
-
Reason for treatment discontinuation (Inadequate BP control, adverse events, others)
-
Adverse events
-
Responder rate: SBP <140mmHg and DBP <90mmHg (SBP <140mmHg and DBP <85mmHg for patients with diabetes mellitus)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 years old patient at the 1st visit
- •Patient who is determined to prescribe Eprosartan for hypertension (patient with at least one of the following conditions) (1) Newly diagnosed hypertension (2) Inability to tolerate hypertension (for example: adverse event) (3) Lack of response to current antihypertensive medications
- •Metabolic syndrome patient (fulfill 3 or more components before enrollment) (1) Waist circumference (>90 for men, >80 for women) (2) Triglycerides (≥150mg/dl) (3) HDL cholesterol (<40mg/dl for men, <50mg/dl for women) (4) SBP≥130mmHg or DBP≥85mmHg or on antihypertensive medications) (5) Fasting glucose level (≥100mg/dl) or on antidiabetic medications
- •MS diagnosis origin: Korean diabetes association
排除标准
- •Patients who is administered with 3 or more than 3 antihypertensive drugs
- •Patients who is contraindicated with Eprosartan by the product label
结局指标
主要结局
To assess the changes of pulse pressure at 12 weeks
时间窗: 12 weeks
Calculating pulse pressure at 3rd(12weeks) visit and it will be presented in descriptive statistics quantity
次要结局
- - changes of pulse pressure at 4, 24 weeks - changes of blood pressure at 4, 12, 24 weeks - Duration to get normalized BP - assess IIEF-5 score - Score changes of Framingham 10-year CHD risk(24 weeks)