Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Compliance of prescribed medication - By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated
研究概览
简要总结
Hypertension and dyslipidemia are very prevalent diseases in general population, and the prevalence is keep increasing especially on population with advanced age. Both diseases are major risk factor of cardiovascular disease, and many complication could be induced if not managed properly. Also, these diseases need consistent medication for long time, so the compliance to the treatment is an important issue for these diseases.
Treatment effect of olmesartan to hypertension and rosuvastatin to dyslipidemia is already proven in previous studies, and these medication does not have interaction with each other. By using fixed-dose combination of these drugs, the investigators could improve the compliance to medication, and may have better treatment effect.
In this single center, randomized, phase 4 clinical trial, the investigators divided patients into 2 groups, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs. Each patient in this study was evaluated at first visit, and outcomes are evaluated at 26 weeks after the start point of medication. The primary outcome of this study was compliance of prescribe medication, and the secondary outcome was blood pressure (systolic, diastolic), cholesterol, and low density lipoprotein cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
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
- •Male and female patients between 20 to 80 years old
- •Patients with at least one condition below
- •Systolic blood pressure is 140mmHg or higher, or diastolic pressure is 90mmHg or higher, and 2 or more cardiovascular risk factor, and low-density lipoprotein cholesterol is 130mg/dL or higher.
- •Systolic blood pressure is 140mmHg or higher, or diastolic pressure is 90mmHg or higher, and 0 or 1 cardiovascular risk factor, and low-density lipoprotein cholesterol is 160mg/dL or higher.
- •Patients with medication for hypertension, and (a) symptomatic coronary artery disease, stroke, peripheral artery disease regardless of low density lipoprotein cholesterol level, or (b) diabetes mellitus, carotid artery stenosis of 50% or higher, aortic aneurysm with low density lipoprotein cholesterol 100mg/dL or higher, or (c) more than 2 cardiovascular risk factor with low density lipoprotein cholesterol 130mg/dL or higher, or (d) 0 or 1 cardiovascular risk factor with low density lipoprotein cholesterol 160mg/dL or higher
- •Patients with medication for dyslipidemia, and systolic blood pressure is 140mmHg or higher or diastolic blood pressure is 90mmHg or higher
- •Patients with medication for hypertension and dyslipidemia
- •Patients who can understand the provided information, and sign the consent form
排除标准
- •Systolic blood pressure is 180mmHg or higher, or diastolic blood pressure is 100mmHg or higher
- •Patient with endocrinologic or metabolic disorder which could affect serum lipid or lipoprotein
- •Uncontrolled diabetes mellitus (HbA1c result at baseline evaluation is 9% or higher, or fasting glucose is 160mg/dL or higher
- •Severe cardiologic disorder (heart failure with NYHA class 3 or 4, heart attack in 6 months, myocardial infarction, heart surgery, percutaneous coronary intervention, unstable angina) or coronary artery bypass surgery in 3 months
- •Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant cardiac arrhythmia judged by the researcher
- •Patient with genetic disease such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Patient with psychotic disease, or drug or alcohol addiction
- •Patient with severe liver cirrhosis, renal failure, or heart failure
- •Patient with systemic infectious disease
- •Patient who had systemic steroid (intravenous, intramuscular, or per oral) within 2 months before screening, or planned to
- •Patient in pregnancy, lactation, or childbearing age without proper contraceptive measure
- •Patient who attended other clinical trial 1 month before screening
- •Patient who seems to be inappropriate to be in clinical trial judged by researcher
研究组 & 干预措施
Patients with fixed-dose combination of 2 drugs
Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs
干预措施: Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination)) (Drug)
Patients with 2 separated drugs
Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease.
干预措施: Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin) (Drug)
结局指标
主要结局
Compliance of prescribed medication - By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated
时间窗: 26 weeks after the start point of medication
Compliance of prescribed medication is compared between 2 groups at 26 weeks after the start point of medication. By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated.
次要结局
- Blood pressure (systolic, diastolic)(26 weeks after the start point of medication)
- Cholesterol (mg/dL)(26 weeks after the start point of medication)
- Low density lipoprotein cholesterol (mg/dL)(26 weeks after the start point of medication)