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出境医 / 临床实验 / Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia (CORONA)

Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia (CORONA)

Study Description
Brief Summary:
This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia

Condition or disease Intervention/treatment Phase
Dyslipidemias Hypertension Drug: Rosuampin 10/5mg Drug: Rosuampin 20/5mg Drug: Amlodipine/Atorvastatin 5/20mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Rosuampin 10/5mg
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
 Drug: Rosuampin 10/5mg
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
Experimental: Rosuampin 20/5mg
Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks
 Drug: Rosuampin 20/5mg
Rosuampin 20/5mg qd for 8 weeks
Active Comparator: Amlodipine/Atorvastatin 5/20mg
Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks
 Drug: Amlodipine/Atorvastatin 5/20mg
Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
Outcome Measures
Primary Outcome Measures :
  1. Rate of change from baseline to week 8 in LDL-Cholesterol [ Time Frame: Baseline/Week 8 ]

Secondary Outcome Measures :
  1. Rate of change from baseline to week 4 in LDL-Cholesterol [ Time Frame: Baseline/Week 4 ]
  2. Proportion of subjects who reached the therapeutic goal to week 8 [ Time Frame: Week 8 ]
    * Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL

  3. Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C) [ Time Frame: Baseline/Week 4, 8 ]
    Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a)

  4. Rate of change from baseline to week 4, 8 in hs-CRP [ Time Frame: Baseline/Week 4, 8 ]
  5. Rate of change from baseline to week 4, 8 in glucose index [ Time Frame: Baseline/Week 4, 8 ]
    Fasting Blood Glucose, HbA1C, HOMA-IR

  6. Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm [ Time Frame: Baseline/Week 4, 8 ]
  7. Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm [ Time Frame: Baseline/Week 4, 8 ]
  8. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) [ Time Frame: Week 8 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Patient with dyslipidemia and hypertension
  • Written informed consent

Exclusion Criteria:

  • Triglyceride ≥ 400 mg/dL at screening
  • Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
  • sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
  • A history of rhabdomyolysis, myopathy
  • Patient with hypersensitivity to Statin or Amlodipine
  • Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
  • Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
  • Contraindications stated in the Label of Rosuampin or Caduet
  • Those participating in other clinical trials for investigational products at screening
  • Patients deemed to be ineligible to participate in the trial by investigator
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Daegu Catholic Univ. Medical Center Recruiting
Daegu, Korea, Republic of
Contact: MalSoon Park    +82-53-650-4344    joonmom77@naver.com   
Principal Investigator: Kee-Sik Kim, MD PhD         
Sponsors and Collaborators
Yuhan Corporation
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date December 14, 2020
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019) 		Rate of change from baseline to week 8 in LDL-Cholesterol [ Time Frame: Baseline/Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Rate of change from baseline to week 4 in LDL-Cholesterol [ Time Frame: Baseline/Week 4 ]
  • Proportion of subjects who reached the therapeutic goal to week 8 [ Time Frame: Week 8 ]
    * Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL
  • Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C) [ Time Frame: Baseline/Week 4, 8 ]
    Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a)
  • Rate of change from baseline to week 4, 8 in hs-CRP [ Time Frame: Baseline/Week 4, 8 ]
  • Rate of change from baseline to week 4, 8 in glucose index [ Time Frame: Baseline/Week 4, 8 ]
    Fasting Blood Glucose, HbA1C, HOMA-IR
  • Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm [ Time Frame: Baseline/Week 4, 8 ]
  • Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm [ Time Frame: Baseline/Week 4, 8 ]
  • The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) [ Time Frame: Week 8 ]
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 Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia
Official Title  ICMJE Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia
Brief Summary This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslipidemias
  • Hypertension
Intervention  ICMJE
  • Drug: Rosuampin 10/5mg
    Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
  • Drug: Rosuampin 20/5mg
    Rosuampin 20/5mg qd for 8 weeks
  • Drug: Amlodipine/Atorvastatin 5/20mg
    Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
Study Arms  ICMJE
  • Experimental: Rosuampin 10/5mg
    Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
    Intervention: Drug: Rosuampin 10/5mg
  • Experimental: Rosuampin 20/5mg
    Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks
    Intervention: Drug: Rosuampin 20/5mg
  • Active Comparator: Amlodipine/Atorvastatin 5/20mg
    Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks
    Intervention: Drug: Amlodipine/Atorvastatin 5/20mg
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Patient with dyslipidemia and hypertension
  • Written informed consent

Exclusion Criteria:

  • Triglyceride ≥ 400 mg/dL at screening
  • Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
  • sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
  • A history of rhabdomyolysis, myopathy
  • Patient with hypersensitivity to Statin or Amlodipine
  • Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
  • Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
  • Contraindications stated in the Label of Rosuampin or Caduet
  • Those participating in other clinical trials for investigational products at screening
  • Patients deemed to be ineligible to participate in the trial by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951207
Other Study ID Numbers  ICMJE YMC040
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 Yuhan Corporation
Study Sponsor  ICMJE Yuhan Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yuhan Corporation
Verification Date December 2020

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

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