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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: Rosuampin 10/5mg; Drug: Rosuampin 20/5mg; Drug: Amlodipine/Atorvastatin 5/20mg

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Daegu Catholic Univ. Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change from baseline to week 4 in LDL-Cholesterol		Baseline/Week 4
Proportion of subjects who reached the therapeutic goal to week 8	* Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL	Week 8
Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)	Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a)	Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in hs-CRP		Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in glucose index	Fasting Blood Glucose, HbA1C, HOMA-IR	Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm		Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm		Baseline/Week 4, 8
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)		Week 8

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2019
• Primary Completion (ACTUAL): September 29, 2021
• Study Completion (ACTUAL): September 29, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (ACTUAL): May 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Atorvastatin; Amlodipine; Amlodipine, atorvastatin drug combination
• Other Study ID Numbers: YMC040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No