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Completed

NCT Number: NCT03951207

Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia

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

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Key information

Conditions

Dyslipidemias Cardiovascular Diseases Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Daegu Catholic Univ. Medical Center

Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuampin 10/5mg

Drug

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Rosuampin 20/5mg

Drug

Rosuampin 20/5mg qd for 8 weeks

Amlodipine/Atorvastatin 5/20mg

Drug

Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Primary outcomes

  1. Rate of change from baseline to week 8 in LDL-Cholesterol

    Time frame: Baseline/Week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Acronym: CORONA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 15, 2019
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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