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Completed

NCT Number: NCT03949374

Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals aged between 19 and 80 years old.
  • The following patients who belong to the low-risk group to the very-high risk group according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).
  • Very high risk group (coronary artery disease, ischemic stroke, peripheral vascular disease) were not receiving lipid-lowering agents (statins) within 4 weeks of the screening, regardless of LDL-C levels
  • High risk group (carotid artery disease, abnormal aneurysm, diabetes)* : LDL-C ≥ 100 mg/dl
  • Moderate risk group (2 or more major risk factors)* : LDL-C ≥ 130 mg/dl
  • Low risk group (less than 1 major risk factors)* : LDL-C ≥ 160 mg/dl
  • If the patients taka a lipid-lowering agents (statin) within 4 weeks of screening, enrolled them after wash-out for 4 weeks or more.
  • Patients who voluntarily participated in the trial and obtained document consent.

Exclusion criteria

  • a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment)
  • uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
  • uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
  • uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
  • usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
  • a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN
  • chronic kidney disease (serum creatinine ≥2 times the ULN)
  • elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)
  • a history of drug or alcohol abuse
  • a history of gastrointestinal surgery or gastrointestinal tract disorders
  • hypersensitivity to the components of this drug
  • those who disagree with contraception
  • pregnancy and/or lactation.

Treatment and study plan

CRESTOR, reference formulation of rosuvastatin

Drug

Use of ROVASRO for hypercholesterolemia

ROVASRO, generic formulation of rosuvastatin

Drug

Use of CRESTOR for hypercholesterolemia

Primary outcomes

  1. Percentage change in the level of LDL-C

    Time frame: 8 weeks after treatment

    Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.

  2. Target achievement rate in the level of LDL-C

    Time frame: 8 weeks after treatment

    Target achievement rate in the level of LDL-C from baseline to week 8 of drug treatment The LDL-C targets were defined as <70 mg/dL for the very high risk group, <100 mg/dL for the high risk group, <130 mg/dL for the moderate risk group, and <160 mg/dL for the low risk group (Committee. KCJ 2016).

Secondary outcomes

  1. Change in biochemical parameters : total cholesterol (mg/dL)

    Time frame: 8 weeks after treatment

    Percentage changes in total cholesterol (mg/dL).

  2. Change in biochemical parameters : triglyceride (mg/dL)

    Time frame: 8 weeks after treatment

    Percentage changes in triglyceride (mg/dL).

  3. Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)

    Time frame: 8 weeks after treatment

    Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL).

  4. Change in biochemical parameters : apolipoprotein B(mg/dL)

    Time frame: 8 weeks after treatment

    Percentage changes in apolipoprotein B(mg/dL).

  5. Change in biochemical parameters : apolipoprotein A1(mg/dL)

    Time frame: 8 weeks after treatment

    Percentage changes in apolipoprotein A1(mg/dL).

  6. Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)

    Time frame: 8 weeks after treatment

    Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L).

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 14, 2019
Registry last updated
May 14, 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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