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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with fixed-dose combination of 2 drugs; Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs	Drug: Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination)); In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.
Active Comparator: Patients with 2 separated drugs; 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); 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2016
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Serine Proteinase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Vasoconstrictor Agents; Rosuvastatin Calcium; Olmesartan; Angiotensin II; Giapreza; Angiotensinogen; Angiotensin Receptor Antagonists
• Other Study ID Numbers: 4-2015-1122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No