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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-23

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

ROVASRO, generic formulation of rosuvastatin

Intervention Type DRUG

Use of CRESTOR for hypercholesterolemia

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

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

Group Type ACTIVE_COMPARATOR

CRESTOR, reference formulation of rosuvastatin

Intervention Type DRUG

Use of ROVASRO for hypercholesterolemia

Interventions

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CRESTOR, reference formulation of rosuvastatin

Use of ROVASRO for hypercholesterolemia

Intervention Type DRUG

ROVASRO, generic formulation of rosuvastatin

Use of CRESTOR for hypercholesterolemia

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No