Clinical trial NCT03949374: Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Dyslipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 126
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Individuals aged between 19 and 80 years old.
2. 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.
3. Patients who voluntarily participated in the trial and obtained document consent.

Exclusion Criteria:

1. 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)
2. uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
3. uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
5. usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
6. a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN
7. chronic kidney disease (serum creatinine ≥2 times the ULN)
8. elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)
9. a history of drug or alcohol abuse
10. a history of gastrointestinal surgery or gastrointestinal tract disorders
11. hypersensitivity to the components of this drug
12. those who disagree with contraception
13. pregnancy and/or lactation.

Primary outcomes:
measure: Percentage change in the level of LDL-C
timeFrame: 8 weeks after treatment
measure: Target achievement rate in the level of LDL-C
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Change in biochemical parameters : total cholesterol (mg/dL)
timeFrame: 8 weeks after treatment
measure: Change in biochemical parameters : triglyceride (mg/dL)
timeFrame: 8 weeks after treatment
measure: Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)
timeFrame: 8 weeks after treatment
measure: Change in biochemical parameters : apolipoprotein B(mg/dL)
timeFrame: 8 weeks after treatment
measure: Change in biochemical parameters : apolipoprotein A1(mg/dL)
timeFrame: 8 weeks after treatment
measure: Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)
timeFrame: 8 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Kim H, Lee CJ, Choi D, Kim BK, Kim IC, Kim JS, Ahn CM, Hong GR, Cho IJ, Shim CY, Lee SH. Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin. J Lipid Atheroscler. 2020 May;9(2):283-290. doi: 10.12997/jla.2020.9.2.283. Epub 2020 Mar 6.