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

Primary Purpose

Hypercholesterolemia, Dyslipidemias

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CRESTOR, reference formulation of rosuvastatin

ROVASRO, generic formulation of rosuvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

10mg of the generic formulation (rosuvastatin, ROVASRO®)

10mg of the reference formulation (rosuvastatin, CRESTOR®)

Arm Description

Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)

Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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

Percentage changes in total cholesterol (mg/dL).

Change in biochemical parameters : triglyceride (mg/dL)

Percentage changes in triglyceride (mg/dL).

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

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

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

Percentage changes in apolipoprotein B(mg/dL).

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

Percentage changes in apolipoprotein A1(mg/dL).

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

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

Full Information

NCT ID

NCT03949374

First Posted

May 3, 2019

Last Updated

May 13, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03949374

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

October 23, 2015 (Actual)

Primary Completion Date

April 16, 2018 (Actual)

Study Completion Date

June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10mg of the generic formulation (rosuvastatin, ROVASRO®)

Arm Type

Active Comparator

Arm Description

Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)

Arm Title

10mg of the reference formulation (rosuvastatin, CRESTOR®)

Arm Type

Active Comparator

Arm Description

Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)

Intervention Type

Drug

Intervention Name(s)

CRESTOR, reference formulation of rosuvastatin

Intervention Description

Use of ROVASRO for hypercholesterolemia

Intervention Type

Drug

Intervention Name(s)

ROVASRO, generic formulation of rosuvastatin

Intervention Description

Use of CRESTOR for hypercholesterolemia

Primary Outcome Measure Information:

Title

Percentage change in the level of LDL-C

Description

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

Time Frame

8 weeks after treatment

Title

Target achievement rate in the level of LDL-C

Description

Time Frame

8 weeks after treatment

Secondary Outcome Measure Information:

Title

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

Description

Percentage changes in total cholesterol (mg/dL).

Time Frame

8 weeks after treatment

Title

Change in biochemical parameters : triglyceride (mg/dL)

Description

Percentage changes in triglyceride (mg/dL).

Time Frame

8 weeks after treatment

Title

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

Description

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

Time Frame

8 weeks after treatment

Title

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

Description

Percentage changes in apolipoprotein B(mg/dL).

Time Frame

8 weeks after treatment

Title

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

Description

Percentage changes in apolipoprotein A1(mg/dL).

Time Frame

8 weeks after treatment

Title

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

Description

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

Time Frame

8 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32821737

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.

Results Reference

derived

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

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