Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))
* Drug: Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are divided into 2 group, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with fixed-dose combination of 2 drugs<br>Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs | Drug: Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))<br>* In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.<br>|
| Active Comparator: Patients with 2 separated drugs<br>Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease. | Drug: Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)<br>* In control group, patients had two separated pills for hypertension and dyslipidemia. One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin, Pravastatin, Fluvastatin and Atorvastatin/Ezetimibe).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of prescribed medication - By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated | 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. | 26 weeks after the start point of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (systolic, diastolic) | Blood pressure(systolic, diastolic) is compared between 2 groups at 26 weeks after the start point of medication | 26 weeks after the start point of medication | 
| Cholesterol (mg/dL) | Cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication | 26 weeks after the start point of medication | 
| Low density lipoprotein cholesterol (mg/dL) | Low density lipoprotein cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication | 26 weeks after the start point of medication |