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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949374
• Other study ID #: 4-2015-0730
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 1, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• CRESTOR, reference formulation of rosuvastatin
Use of ROVASRO for hypercholesterolemia
• ROVASRO, generic formulation of rosuvastatin
Use of CRESTOR for hypercholesterolemia

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in biochemical parameters : total cholesterol (mg/dL)	Percentage changes in total cholesterol (mg/dL).	8 weeks after treatment
Secondary	Change in biochemical parameters : triglyceride (mg/dL)	Percentage changes in triglyceride (mg/dL).	8 weeks after treatment
Secondary	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
Secondary	Change in biochemical parameters : apolipoprotein B(mg/dL)	Percentage changes in apolipoprotein B(mg/dL).	8 weeks after treatment
Secondary	Change in biochemical parameters : apolipoprotein A1(mg/dL)	Percentage changes in apolipoprotein A1(mg/dL).	8 weeks after treatment
Secondary	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