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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with fixed-dose combination of 2 drugs | Experimental | Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs |
|
| Patients with 2 separated drugs | Active Comparator | Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination)) | Drug | In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills. |
| 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 |
| 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) |
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Inclusion Criteria:
Male and female patients between 20 to 80 years old
Patients with at least one condition below
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu | Seoul | South Korea |
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Patients are divided into 2 group, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs.
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No masking
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| Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin) | Drug | 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). |
|
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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C437965 | olmesartan |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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