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Completed

NCT Number: NCT04061824

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

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

Drug

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 outcomes

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

    Time frame: 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 outcomes

  1. Blood pressure (systolic, diastolic)

    Time frame: 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

  2. Cholesterol (mg/dL)

    Time frame: 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

  3. Low density lipoprotein cholesterol (mg/dL)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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