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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951207
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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

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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 : August 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


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




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 ]


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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

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): NCT03951207


Locations
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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
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03951207    
Other Study ID Numbers: YMC040
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: July 5, 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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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents