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

Primary Purpose

Dyslipidemias, Hypertension

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Rosuampin 10/5mg

Rosuampin 20/5mg

Amlodipine/Atorvastatin 5/20mg

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Daegu Catholic Univ. Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Rosuampin 10/5mg

Rosuampin 20/5mg

Amlodipine/Atorvastatin 5/20mg

Arm Description

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of change from baseline to week 4 in LDL-Cholesterol

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

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)

Rate of change from baseline to week 4, 8 in hs-CRP

Rate of change from baseline to week 4, 8 in glucose index

Fasting Blood Glucose, HbA1C, HOMA-IR

Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm

Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm

The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)

Full Information

NCT ID

NCT03951207

First Posted

May 13, 2019

Last Updated

October 10, 2022

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03951207

Brief Title

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

Acronym

CORONA

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

May 30, 2019 (Actual)

Primary Completion Date

September 29, 2021 (Actual)

Study Completion Date

September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

259 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuampin 10/5mg

Arm Type

Experimental

Arm Description

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Arm Title

Rosuampin 20/5mg

Arm Type

Experimental

Arm Description

Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Arm Title

Amlodipine/Atorvastatin 5/20mg

Arm Type

Active Comparator

Arm Description

Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Rosuampin 10/5mg

Intervention Description

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Rosuampin 20/5mg

Intervention Description

Rosuampin 20/5mg qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Amlodipine/Atorvastatin 5/20mg

Intervention Description

Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline/Week 8

Secondary Outcome Measure Information:

Title

Rate of change from baseline to week 4 in LDL-Cholesterol

Time Frame

Baseline/Week 4

Title

Proportion of subjects who reached the therapeutic goal to week 8

Description

* Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL

Time Frame

Week 8

Title

Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)

Description

Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a)

Time Frame

Baseline/Week 4, 8

Title

Rate of change from baseline to week 4, 8 in hs-CRP

Time Frame

Baseline/Week 4, 8

Title

Rate of change from baseline to week 4, 8 in glucose index

Description

Fasting Blood Glucose, HbA1C, HOMA-IR

Time Frame

Baseline/Week 4, 8

Title

Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm

Time Frame

Baseline/Week 4, 8

Title

Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm

Time Frame

Baseline/Week 4, 8

Title

The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Daegu Catholic Univ. Medical Center

City

Daegu

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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