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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949374
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemias Drug: CRESTOR, reference formulation of rosuvastatin Drug: ROVASRO, generic formulation of rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2015
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10mg of the generic formulation (rosuvastatin, ROVASRO®)
Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)
Drug: ROVASRO, generic formulation of rosuvastatin
Use of CRESTOR for hypercholesterolemia

Active Comparator: 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Drug: CRESTOR, reference formulation of rosuvastatin
Use of ROVASRO for hypercholesterolemia




Primary Outcome Measures :
  1. Percentage change in the level of LDL-C [ Time Frame: 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.

  2. Target achievement rate in the level of LDL-C [ Time Frame: 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 :
  1. Change in biochemical parameters : total cholesterol (mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in total cholesterol (mg/dL).

  2. Change in biochemical parameters : triglyceride (mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in triglyceride (mg/dL).

  3. Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL).

  4. Change in biochemical parameters : apolipoprotein B(mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in apolipoprotein B(mg/dL).

  5. Change in biochemical parameters : apolipoprotein A1(mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in apolipoprotein A1(mg/dL).

  6. Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L).



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949374


Locations
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Korea, Republic of
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03949374    
Other Study ID Numbers: 4-2015-0730
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors