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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Dyslipidemias; Hypercholesterolemia

Treatments: Drug: ROVASRO, generic formulation of rosuvastatin; Drug: CRESTOR, reference formulation of rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03949374

4-2015-0730

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: ROVASRO, generic formulation of rosuvastatin

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

Active Comparator group

Description:

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

Treatment:

Drug: CRESTOR, reference formulation of rosuvastatin