Status:
COMPLETED
Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia
Lead Sponsor:
Yonsei University
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04061824
Start Date
May 24 2016
End Date
December 20 2018
Last Update
August 21 2019
Active Locations (1)
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1
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Seoul, South Korea