Clinical trial NCT04061824: Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia
Official title: Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are divided into 2 group, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs.
Primary purpose: OTHER

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 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.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients between 20 to 80 years old
2. 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
3. Patients who can understand the provided information, and sign the consent form

Exclusion Criteria:

1. Systolic blood pressure is 180mmHg or higher, or diastolic blood pressure is 100mmHg or higher
2. 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
3. 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
4. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant cardiac arrhythmia judged by the researcher
5. Patient with genetic disease such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
6. Patient with psychotic disease, or drug or alcohol addiction
7. Patient with severe liver cirrhosis, renal failure, or heart failure
8. Patient with systemic infectious disease
9. Patient who had systemic steroid (intravenous, intramuscular, or per oral) within 2 months before screening, or planned to
10. Patient in pregnancy, lactation, or childbearing age without proper contraceptive measure
11. Patient who attended other clinical trial 1 month before screening
12. Patient who seems to be inappropriate to be in clinical trial judged by researcher

Primary outcomes:
measure: Compliance of prescribed medication - By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated
timeFrame: 26 weeks after the start point of medication
Secondary outcomes:
measure: Blood pressure (systolic, diastolic)
timeFrame: 26 weeks after the start point of medication
measure: Cholesterol (mg/dL)
timeFrame: 26 weeks after the start point of medication
measure: Low density lipoprotein cholesterol (mg/dL)
timeFrame: 26 weeks after the start point of medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Study officials:
References: