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

Phase 4

Completed

• Conditions: Hypertension; Dyslipidemias
• Interventions: Drug: Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination)); Drug: Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)

• Registration Number: NCT04061824
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-24
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Study First Submitted: 2019-07-26
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with fixed-dose combination of 2 drugs	Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))	Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs
Patients with 2 separated drugs	Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)	Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease.

Primary Outcome Measures

Name	Time	Method
Compliance of prescribed 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	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure (systolic, diastolic)	26 weeks after the start point of medication	Blood pressure(systolic, diastolic) is compared between 2 groups at 26 weeks after the start point of medication
Cholesterol (mg/dL)	26 weeks after the start point of medication	Cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication
Low density lipoprotein cholesterol (mg/dL)	26 weeks after the start point of medication	Low density lipoprotein cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication

Trial Locations

Locations (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu; 🇰🇷 Seoul, Korea, Republic of