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

Phase 4

Completed

• Conditions: Hypercholesterolemia; Dyslipidemias
• Interventions: Drug: ROVASRO, generic formulation of rosuvastatin; Drug: CRESTOR, reference formulation of rosuvastatin

• Registration Number: NCT03949374
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-23
• Primary Completion: 2018-04-16
• Study Completion: 2018-06-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-13
• Last Update Submitted: 2019-05-13
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10mg of the generic formulation (rosuvastatin, ROVASRO®)	ROVASRO, generic formulation of rosuvastatin	Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)
10mg of the reference formulation (rosuvastatin, CRESTOR®)	CRESTOR, reference formulation of rosuvastatin	Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)

Primary Outcome Measures

Name	Time	Method
Percentage change in the level of LDL-C	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.
Target achievement rate in the level of LDL-C	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 Outcome Measures

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

Trial Locations

Locations (1)

Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of