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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 29, 2021

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Rosuampin 10/5mg
    • Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
  • Experimental: Rosuampin 20/5mg
    • Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks
  • Active Comparator: Amlodipine/Atorvastatin 5/20mg
    • Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Rate of change from baseline to week 8 in LDL-Cholesterol
    • Time Frame: Baseline/Week 8

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yuhan Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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