DyslipidemiasPhase 4CORONANCT03951207
Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia
A Phase 4 study testing Rosuampin 10/5mg, Rosuampin 20/5mg and Amlodipine/Atorvastatin 5/20mg in people with Dyslipidemias and Hypertension, run by Yuhan Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias, Hypertension
- What is being tested?
- Rosuampin 10/5mg, Rosuampin 20/5mg and Amlodipine/Atorvastatin 5/20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2019to 29 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both man and woman who is over 19 years old
- Patient with dyslipidemia and hypertension
- Written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
- Conditions
- Dyslipidemias, Hypertension
- Being tested
- Rosuampin 10/5mg, Rosuampin 20/5mg, Amlodipine/Atorvastatin 5/20mg
- Medical subject headings
- Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuampin 10/5mgDrug
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
Rosuampin 20/5mgDrug
Rosuampin 20/5mg qd for 8 weeks
Amlodipine/Atorvastatin 5/20mgDrug
Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosuampin 10/5mg | Experimental | Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks Receives: Drug: Rosuampin 10/5mg |
| Rosuampin 20/5mg | Experimental | Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks Receives: Drug: Rosuampin 20/5mg |
| Amlodipine/Atorvastatin 5/20mg | Active comparator | Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks Receives: Drug: Amlodipine/Atorvastatin 5/20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change from baseline to week 8 in LDL-Cholesterol
Measured: Baseline/Week 8
Secondary outcomes (8)
Rate of change from baseline to week 4 in LDL-Cholesterol
Measured: 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
Measured: 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)
Measured: Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in hs-CRP
Measured: Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in glucose index
Fasting Blood Glucose, HbA1C, HOMA-IR
Measured: Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm
Measured: Baseline/Week 4, 8
Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm
Measured: Baseline/Week 4, 8
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start30 May 2019
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951207
- Sponsor's protocol ID
- YMC040
- Acronym
- CORONA
- Status last verified
- Dec 2020
- First submitted
- 13 May 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park CM, Jung HW. Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials. J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363.
PubMed 40429358Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, Kim KS. Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia. J Clin Hypertens (Greenwich). 2023 Sep;25(9):828-844. doi: 10.1111/jch.14715. Epub 2023 Aug 16.
PubMed 37584254
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03951207
- Acronym / sponsor ID
- CORONA / YMC040
- Conditions
- Dyslipidemias, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rosuampin 10/5mg | Experimental | Drug: Rosuampin 10/5mgRosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks |
| Rosuampin 20/5mg | Experimental | Drug: Rosuampin 20/5mgRosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
| Amlodipine/Atorvastatin 5/20mg | Active comparator | Drug: Amlodipine/Atorvastatin 5/20mgAtorvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both man and woman who is over 19 years old
- Patient with dyslipidemia and hypertension
- Written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuampin 10/5mgRosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks | Drug | Rosuampin 10/5mg |
| Rosuampin 20/5mgRosuampin 20/5mg qd for 8 weeks | Drug | Rosuampin 20/5mg |
| Amlodipine/Atorvastatin 5/20mgAmlodipine/Atorvastatin 5/20mg qd for 8 weeks | Drug | Amlodipine/Atorvastatin 5/20mg |
Primary outcome
Rate of change from baseline to week 8 in LDL-Cholesterol
Time frame: Baseline/Week 8
8 secondary outcomes
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
Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)
Time frame: Baseline/Week 4, 8
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 40429358Park CM, Jung HW. Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials. J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363.
- Derived from this study: PubMed 37584254Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, Kim KS. Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia. J Clin Hypertens (Greenwich). 2023 Sep;25(9):828-844. doi: 10.1111/jch.14715. Epub 2023 Aug 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuampin 10/5mg, Rosuampin 20/5mg and Amlodipine/Atorvastatin 5/20mg in people with Dyslipidemias and Hypertension, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change from baseline to week 8 in LDL-Cholesterol (time frame: Baseline/Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.