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

Primary Purpose

Hypertension, Dyslipidemias

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))

Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with fixed-dose combination of 2 drugs

Patients with 2 separated drugs

Arm Description

Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs

Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure (systolic, diastolic)

Blood pressure(systolic, diastolic) is compared between 2 groups at 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

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

Full Information

NCT ID

NCT04061824

First Posted

July 26, 2019

Last Updated

August 19, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT04061824

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

May 24, 2016 (Actual)

Primary Completion Date

December 20, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Dyslipidemias

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients are divided into 2 group, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs.

Masking

None (Open Label)

Masking Description

No masking

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with fixed-dose combination of 2 drugs

Arm Type

Experimental

Arm Description

Medication for hypertension and dyslipidemia in these group was fixed-dose combination of 2 drugs

Arm Title

Patients with 2 separated drugs

Arm Type

Active Comparator

Arm Description

Medication for hypertension and dyslipidemia in these group was 2 separated drugs for each disease.

Intervention Type

Drug

Intervention Name(s)

Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))

Intervention Description

In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.

Intervention Type

Drug

Intervention Name(s)

Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Compliance of prescribed medication - By using the number of prescribed pills and remained pills, the percentage of admitted drugs were calculated

Description

Time Frame

26 weeks after the start point of medication

Secondary Outcome Measure Information:

Title

Blood pressure (systolic, diastolic)

Description

Blood pressure(systolic, diastolic) is compared between 2 groups at 26 weeks after the start point of medication

Time Frame

26 weeks after the start point of medication

Title

Cholesterol (mg/dL)

Description

Cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication

Time Frame

26 weeks after the start point of medication

Title

Low density lipoprotein cholesterol (mg/dL)

Description

Low density lipoprotein cholesterol(mg/dL) is compared between 2 groups at 26 weeks after the start point of medication

Time Frame

26 weeks after the start point of medication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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