ASCVDPhase 4NCT03494270
High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients
A Phase 4 study testing Rosuvamibe and Monorova in people with ASCVD, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- ASCVD
- What is being tested?
- Rosuvamibe and Monorova
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2018to 26 Sep 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 to 75 years
- Patients diagnosed with ASCVD (coronary artery disease)
- acute coronary syndrome
- history of myocardial infarction (MI)
- stable or unstable angina
- history of coronary revascularization
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- stroke or transient ischemic attack (TIA)
- peripheral arterial disease, history of peripheral arterial revascularization
- Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
- Written informed consent
Who cannot join
- Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
- Fasting triglyceride ≥ 400 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to rosuvastatin or ezetemibe
- Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
- ① Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
Show all 10Show fewer
- ② ALT, AST > 3x ULN or history of active liver disease
- ③ CPK > 3x ULN
- Administration of other investigational products within 30 days prior to screening visit
- Other than the above who is 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: A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients
This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
- Conditions
- ASCVD
- Being tested
- Rosuvamibe, Monorova
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvamibeDrug
Rosuvastatin 10mg/Ezetimibe 10mg
MonorovaDrug
Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvamibe Tab | Experimental | Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks Receives: Drug: Rosuvamibe |
| Monorova Tab | Active comparator | Rosuvastatin 20mg qd for 24 weeks Receives: Drug: Monorova |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 in LDL-C level
Measured: Baseline, Week 12
Secondary outcomes (9)
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Measured: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Measured: Baseline, Week 12, Week 24
Occurrence of Statin-Associated Muscle Symptoms (SAMS)
Measured: Up to 24 weeks
Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN
Measured: Baseline, Week 12, Week 24
Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN
Measured: Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start18 Mar 2018
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASCVDStudies 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
- 270 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
- NCT03494270
- Sponsor's protocol ID
- YMC033
- Status last verified
- Dec 2019
- First submitted
- 2 Apr 2018
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi H, Kang SH, Jeong SW, Yoon CH, Youn TJ, Song WH, Jeon DW, Lim SW, Lee JH, Cho SW, Chae IH, Kim CH. Lipid-Lowering Efficacy of Combination Therapy With Moderate-Intensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy: A Randomized, Open-Label, Non-Inferiority Trial From Korea. J Lipid Atheroscler. 2023 Sep;12(3):277-289. doi: 10.12997/jla.2023.12.3.277. Epub 2023 Aug 3.
PubMed 37800112
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients
- ClinicalTrials.gov ID
- NCT03494270
- Acronym / sponsor ID
- YMC033
- Conditions
- ASCVD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 11 Apr 2018 (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 will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvamibe Tab | Experimental | Drug: RosuvamibeRosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks |
| Monorova Tab | Active comparator | Drug: MonorovaRosuvastatin 20mg qd for 24 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 19 to 75 years
- Patients diagnosed with ASCVD (coronary artery disease)
- Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
- Written informed consent
Key exclusion criteria (10 listed)
- Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
- Fasting triglyceride ≥ 400 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to rosuvastatin or ezetemibe
- Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
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 |
|---|---|---|
| RosuvamibeRosuvastatin 10mg/Ezetimibe 10mg | Drug | Rosuvamibe Tab |
| MonorovaRosuvastatin 20mg | Drug | Monorova Tab |
Primary outcome
Change from baseline to week 12 in LDL-C level
Time frame: Baseline, Week 12
9 secondary outcomes
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Time frame: Baseline, Week 12, Week 24
Occurrence of Statin-Associated Muscle Symptoms (SAMS)
Time frame: Up to 24 weeks
Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN
Time frame: Baseline, Week 12, Week 24
Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN
Time frame: Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Time frame: Up to 24 weeks
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 30 Dec 2019.
- Derived from this study: PubMed 37800112Choi H, Kang SH, Jeong SW, Yoon CH, Youn TJ, Song WH, Jeon DW, Lim SW, Lee JH, Cho SW, Chae IH, Kim CH. Lipid-Lowering Efficacy of Combination Therapy With Moderate-Intensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy: A Randomized, Open-Label, Non-Inferiority Trial From Korea. J Lipid Atheroscler. 2023 Sep;12(3):277-289. doi: 10.12997/jla.2023.12.3.277. Epub 2023 Aug 3.
- Individual participant dataSharing planned: Undecided
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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 Rosuvamibe and Monorova in people with ASCVD, 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 10 inclusion and 10 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 30 Dec 2019. 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?
Change from baseline to week 12 in LDL-C level (time frame: Baseline, Week 12). 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 NCT03494270, which also lists 1 linked publication.
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 30 Dec 2019.