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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Hypercholesterolemia
• Intervention / Treatment: Drug: ROVASRO, generic formulation of rosuvastatin; Drug: CRESTOR, reference formulation of rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10mg of the generic formulation (rosuvastatin, ROVASRO®); Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)	Drug: ROVASRO, generic formulation of rosuvastatin; Use of CRESTOR for hypercholesterolemia
Active Comparator: 10mg of the reference formulation (rosuvastatin, CRESTOR®); Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)	Drug: CRESTOR, reference formulation of rosuvastatin; Use of ROVASRO for hypercholesterolemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in the level of LDL-C	Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.	8 weeks after treatment
Target achievement rate in the level of LDL-C	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).	8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biochemical parameters : total cholesterol (mg/dL)	Percentage changes in total cholesterol (mg/dL).	8 weeks after treatment
Change in biochemical parameters : triglyceride (mg/dL)	Percentage changes in triglyceride (mg/dL).	8 weeks after treatment
Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)	Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL).	8 weeks after treatment
Change in biochemical parameters : apolipoprotein B(mg/dL)	Percentage changes in apolipoprotein B(mg/dL).	8 weeks after treatment
Change in biochemical parameters : apolipoprotein A1(mg/dL)	Percentage changes in apolipoprotein A1(mg/dL).	8 weeks after treatment
Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)	Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L).	8 weeks after treatment

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 4-2015-0730

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