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出境医 / 临床实验 / Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

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

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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).


Eligibility Criteria
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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.
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE October 23, 2015
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Change in biochemical parameters : total cholesterol (mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in total cholesterol (mg/dL).
  • Change in biochemical parameters : triglyceride (mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in triglyceride (mg/dL).
  • 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).
  • Change in biochemical parameters : apolipoprotein B(mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in apolipoprotein B(mg/dL).
  • Change in biochemical parameters : apolipoprotein A1(mg/dL) [ Time Frame: 8 weeks after treatment ]
    Percentage changes in apolipoprotein A1(mg/dL).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidemias
Intervention  ICMJE
  • Drug: CRESTOR, reference formulation of rosuvastatin
    Use of ROVASRO for hypercholesterolemia
  • Drug: ROVASRO, generic formulation of rosuvastatin
    Use of CRESTOR for hypercholesterolemia
Study Arms  ICMJE
  • Active Comparator: 10mg of the generic formulation (rosuvastatin, ROVASRO®)
    Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)
    Intervention: Drug: ROVASRO, generic formulation of rosuvastatin
  • Active Comparator: 10mg of the reference formulation (rosuvastatin, CRESTOR®)
    Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)
    Intervention: Drug: CRESTOR, reference formulation of rosuvastatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2019) 		126
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949374
Other Study ID Numbers  ICMJE 4-2015-0730
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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