HypercholesterolemiaPhase 4NCT03949374
Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
A Phase 4 study testing CRESTOR, reference formulation of rosuvastatin and ROVASRO, generic formulation of rosuvastatin in people with Hypercholesterolemia and Dyslipidemias, run by Yonsei University at 1 site in South Korea.
Trial summary
This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemias
- What is being tested?
- CRESTOR, reference formulation of rosuvastatin and ROVASRO, generic formulation of rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2015to 1 Jun 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 19 and 80 years old.
- The following patients who belong to the low-risk group to the very-high risk group according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).
- Very high risk group (coronary artery disease, ischemic stroke, peripheral vascular disease) were not receiving lipid-lowering agents (statins) within 4 weeks of the screening, regardless of LDL-C levels
- High risk group (carotid artery disease, abnormal aneurysm, diabetes)* : LDL-C ≥ 100 mg/dl
- Moderate risk group (2 or more major risk factors)* : LDL-C ≥ 130 mg/dl
- Low risk group (less than 1 major risk factors)* : LDL-C ≥ 160 mg/dl
- If the patients taka a lipid-lowering agents (statin) within 4 weeks of screening, enrolled them after wash-out for 4 weeks or more.
- Patients who voluntarily participated in the trial and obtained document consent.
Who cannot join
- a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment)
- uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
- uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
- uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
- usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
- a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN
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- chronic kidney disease (serum creatinine ≥2 times the ULN)
- elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)
- a history of drug or alcohol abuse
- a history of gastrointestinal surgery or gastrointestinal tract disorders
- hypersensitivity to the components of this drug
- those who disagree with contraception
- pregnancy and/or lactation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Being tested
- CRESTOR, reference formulation of rosuvastatin, ROVASRO, generic formulation of rosuvastatin
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRESTOR, reference formulation of rosuvastatinDrug
Use of ROVASRO for hypercholesterolemia
ROVASRO, generic formulation of rosuvastatinDrug
Use of CRESTOR for hypercholesterolemia
| Study group | Role | What they receive |
|---|---|---|
| 10mg of the generic formulation (rosuvastatin, ROVASRO®) | Active comparator | Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®) Receives: Drug: ROVASRO, generic formulation of rosuvastatin |
| 10mg of the reference formulation (rosuvastatin, CRESTOR®) | Active comparator | Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®) Receives: Drug: CRESTOR, reference formulation of rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in the level of LDL-C
Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.
Measured: 8 weeks after treatment
Target achievement rate in the level of LDL-C
Target achievement rate in the level of LDL-C from baseline to week 8 of drug treatment The LDL-C targets were defined as <70 mg/dL for the very high risk group, <100 mg/dL for the high risk group, <130 mg/dL for the moderate risk group, and <160 mg/dL for the low risk group (Committee. KCJ 2016).
Measured: 8 weeks after treatment
Secondary outcomes (6)
Change in biochemical parameters : total cholesterol (mg/dL)
Percentage changes in total cholesterol (mg/dL).
Measured: 8 weeks after treatment
Change in biochemical parameters : triglyceride (mg/dL)
Percentage changes in triglyceride (mg/dL).
Measured: 8 weeks after treatment
Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)
Percentage changes in high-density lipoprotein-cholesterol(HDL-C)(mg/dL).
Measured: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein B(mg/dL)
Percentage changes in apolipoprotein B(mg/dL).
Measured: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein A1(mg/dL)
Percentage changes in apolipoprotein A1(mg/dL).
Measured: 8 weeks after treatment
Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)
Percentage changes in high sensitivity C-reactive protein (hsCRP)(mg/L).
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start23 Oct 2015
- Primary completion16 Apr 2018
- Study completion1 Jun 2018
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 HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Model description
- 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949374
- Sponsor's protocol ID
- 4-2015-0730
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim H, Lee CJ, Choi D, Kim BK, Kim IC, Kim JS, Ahn CM, Hong GR, Cho IJ, Shim CY, Lee SH. Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin. J Lipid Atheroscler. 2020 May;9(2):283-290. doi: 10.12997/jla.2020.9.2.283. Epub 2020 Mar 6.
PubMed 32821737
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT03949374
- Acronym / sponsor ID
- 4-2015-0730
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 14 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 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
| Arm | Type | Receives |
|---|---|---|
| 10mg of the generic formulation (rosuvastatin, ROVASRO®) | Active comparator | Drug: ROVASRO, generic formulation of rosuvastatinTaking 10mg of the generic formulation (rosuvastatin, ROVASRO®) |
| 10mg of the reference formulation (rosuvastatin, CRESTOR®) | Active comparator | Drug: CRESTOR, reference formulation of rosuvastatinTaking 10mg of the reference formulation (rosuvastatin, CRESTOR®) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals aged between 19 and 80 years old.
- The following patients who belong to the low-risk group to the very-high risk group according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).
- Patients who voluntarily participated in the trial and obtained document consent.
Key exclusion criteria (13 listed)
- a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment)
- uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
- uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
- uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
- usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
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 |
|---|---|---|
| CRESTOR, reference formulation of rosuvastatinUse of ROVASRO for hypercholesterolemia | Drug | 10mg of the reference formulation (rosuvastatin, CRESTOR®) |
| ROVASRO, generic formulation of rosuvastatinUse of CRESTOR for hypercholesterolemia | Drug | 10mg of the generic formulation (rosuvastatin, ROVASRO®) |
Primary outcome
Percentage change in the level of LDL-C
Time frame: 8 weeks after treatment
Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.
Target achievement rate in the level of LDL-C
Time frame: 8 weeks after treatment
Target achievement rate in the level of LDL-C from baseline to week 8 of drug treatment The LDL-C targets were defined as <70 mg/dL for the very high risk group, <100 mg/dL for the high risk group, <130 mg/dL for the moderate risk group, and <160 mg/dL for the low risk group (Committee. KCJ 2016).
6 secondary outcomes
Change in biochemical parameters : total cholesterol (mg/dL)
Time frame: 8 weeks after treatment
Change in biochemical parameters : triglyceride (mg/dL)
Time frame: 8 weeks after treatment
Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)
Time frame: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein B(mg/dL)
Time frame: 8 weeks after treatment
Change in biochemical parameters : apolipoprotein A1(mg/dL)
Time frame: 8 weeks after treatment
Change in biochemical parameters : high sensitivity C-reactive protein (hsCRP)(mg/L)
Time frame: 8 weeks after treatment
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 14 May 2019.
- Derived from this study: PubMed 32821737Kim H, Lee CJ, Choi D, Kim BK, Kim IC, Kim JS, Ahn CM, Hong GR, Cho IJ, Shim CY, Lee SH. Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin. J Lipid Atheroscler. 2020 May;9(2):283-290. doi: 10.12997/jla.2020.9.2.283. Epub 2020 Mar 6.
- 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 CRESTOR, reference formulation of rosuvastatin and ROVASRO, generic formulation of rosuvastatin in people with Hypercholesterolemia and Dyslipidemias, run by Yonsei University 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 8 inclusion and 13 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 14 May 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?
Percentage change in the level of LDL-C (time frame: 8 weeks after treatment). The study lists 2 primary outcomes in all. 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 NCT03949374, 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 14 May 2019.