HypercholesterolemiaPhase 3NCT03288038
The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
A Phase 3 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia, run by Shin Poong Pharmaceutical Co. Ltd. at 20 sites in South Korea.
Trial summary
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin and Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 13 Oct 2014to 19 Nov 2015
- Phase
- Phase 3
- 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
- Adults aged 19 years or older
- Patients with primary hypercholesterolemia
- Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative
- those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III
Who cannot join
- Patients with hypersensitivity to the investigational product or its ingredients
- Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
- Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date
- Those with a history of malignant tumor within 5 years
- Those with a history of myopathy or rhabdomyolysis
- Those who show clinically significant confirmed laboratory test results (1) Patients showing AST or ALT level of greater than 2 times the institutional upper limit of normal or those with active liver disease or chronic hepatitis (2) A serum creatinine level greater than 2 times the institutional upper limit of normal (3) HbA1c > 9% (4) Those with TSH level of greater than 1.5 times the institutional upper limit of normal (5) Those with CK level greater than 2 times the institutional upper limit of normal (However, except for an increase caused by a recent trauma, intramuscular injection or strenuous exercise)
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- Those who were given, within 4 weeks prior to the baseline (8 weeks in case of fibrate) or are expected to be given during the study period, a drug that can have an effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase inhibitor, macrolide class antibiotics, etc.)
- Patients who were given estrogen within 3 months from the screening or those who are expected to be given an administration during the study period. (However, a patient who is under a hormone replacement therapy (HRT) will be allowed if no dose change is expected in the course of the clinical study.)
- Those with a history of alcohol or drug abuse
- Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Pregnant or breast-feeding women
- Women of childbearing potential or men who do not intend to use an adequate contraceptive measure during the study period and for 4 weeks after the end of the study(Adequate contraception: Administration and transplantation of a progestin-only contraceptive pill, intrauterine device, condom, spermicidal agent, etc.)
- Patients who participated in another clinical study within 3 months from the screening date or have not had a washout period of at least 5 times the half-life of the active ingredient of the previously administered investigational product, whichever is longer
- Those with drug malabsorption
- Patients who has been judged by the investigator to be ineligible to participate in the clinical study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Chungbuk National University Hospital
Cheongju-si
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Dongguk University Ilsan Hospital
Goyang-si
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Boramae Hospital
Seoul
Chung-Ang University Hospital
Seoul
Gangnam Severance Hospital
Seoul
Hanyang University Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
KyungHee University Hospital
Seoul
Seoul National University Hospital
Seoul
Soon Chun Hyang University Hospital Seoul
Seoul
Ajou University Hospital
Suwon
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
EzetimibeDrug
| Study group | Role | What they receive |
|---|---|---|
| RSV5mg + EZE 10mg | Experimental | Rosuvastatin 5mg/Ezetimibe 10mg Receives: Drug: Rosuvastatin; Drug: Ezetimibe |
| RSV5mg | Active comparator | Rosuvastatin 5mg Receives: Drug: Rosuvastatin |
| RSV10mg + EZE10mg | Experimental | Rosuvastatin 10mg/ Ezetimibe 10mg Receives: Drug: Rosuvastatin; Drug: Ezetimibe |
| RSV10mg | Active comparator | Rosuvastatin 10mg Receives: Drug: Rosuvastatin |
| RSV20mg + EZE10mg | Experimental | Rosuvastatin 20mg/Ezetimibe 10mg Receives: Drug: Rosuvastatin; Drug: Ezetimibe |
| RSV20mg | Active comparator | Rosuvastatin 20mg Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 8 week in LDL-Cholesterol
Measured: baseline and 8 week
Secondary outcomes (5)
Percent change from baseline to 4 week in LDL-Cholesterol
Measured: baseline and 4 week
The change in the LDL-C level from the baseline to Week 4 and Week 8
Measured: baseline to 4 and 8 week
The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8
Measured: baseline to 4 and 8 week
The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8
Measured: baseline to 4 and 8 week
The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8
Measured: baseline to 4 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start13 Oct 2014
- Primary completion19 Nov 2015
- Study completion19 Nov 2015
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288038
- Sponsor's protocol ID
- SP-RE-003
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim W, Yoon YE, Shin SH, Bae JW, Hong BK, Hong SJ, Sung KC, Han SH, Kim W, Rhee MY, Kim SH, Lee SE, Hyon MS, Hwang GS, Son JW, Kim JY, Kim MK, Kim SW, Park JH, Shin JH, Park CG. Efficacy and Safety of Ezetimibe and Rosuvastatin Combination Therapy Versus Those of Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia. Clin Ther. 2018 Jun;40(6):993-1013. doi: 10.1016/j.clinthera.2018.04.015. Epub 2018 May 30.
PubMed 29857919
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03288038
- Acronym / sponsor ID
- SP-RE-003
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 19 Nov 2015 (actual)
- Study completion
- 19 Nov 2015 (actual)
- First posted
- 19 Sep 2017 (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.
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RSV5mg + EZE 10mg | Experimental | Drug: Rosuvastatin, Drug: EzetimibeRosuvastatin 5mg/Ezetimibe 10mg |
| RSV5mg | Active comparator | Drug: RosuvastatinRosuvastatin 5mg |
| RSV10mg + EZE10mg | Experimental | Drug: Rosuvastatin, Drug: EzetimibeRosuvastatin 10mg/ Ezetimibe 10mg |
| RSV10mg | Active comparator | Drug: RosuvastatinRosuvastatin 10mg |
| RSV20mg + EZE10mg | Experimental | Drug: Rosuvastatin, Drug: EzetimibeRosuvastatin 20mg/Ezetimibe 10mg |
| RSV20mg | Active comparator | Drug: RosuvastatinRosuvastatin 20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 years or older
- Patients with primary hypercholesterolemia
- Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative
- those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III
Key exclusion criteria (15 listed)
- Patients with hypersensitivity to the investigational product or its ingredients
- Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
- Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date
- Those with a history of malignant tumor within 5 years
- Those with a history of myopathy or rhabdomyolysis
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 |
|---|---|---|
| Rosuvastatin | Drug | RSV10mg, RSV10mg + EZE10mg, RSV20mg, RSV20mg + EZE10mg, RSV5mg, RSV5mg + EZE 10mg |
| Ezetimibe | Drug | RSV10mg + EZE10mg, RSV20mg + EZE10mg, RSV5mg + EZE 10mg |
Primary outcome
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week
5 secondary outcomes
Percent change from baseline to 4 week in LDL-Cholesterol
Time frame: baseline and 4 week
The change in the LDL-C level from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8
Time frame: baseline to 4 and 8 week
The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8
Time frame: baseline to 4 and 8 week
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 19 Sep 2017.
- Derived from this study: PubMed 29857919Kim W, Yoon YE, Shin SH, Bae JW, Hong BK, Hong SJ, Sung KC, Han SH, Kim W, Rhee MY, Kim SH, Lee SE, Hyon MS, Hwang GS, Son JW, Kim JY, Kim MK, Kim SW, Park JH, Shin JH, Park CG. Efficacy and Safety of Ezetimibe and Rosuvastatin Combination Therapy Versus Those of Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia. Clin Ther. 2018 Jun;40(6):993-1013. doi: 10.1016/j.clinthera.2018.04.015. Epub 2018 May 30.
- 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia, run by Shin Poong Pharmaceutical Co. Ltd. at 20 sites 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 4 inclusion and 15 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent change from baseline to 8 week in LDL-Cholesterol (time frame: baseline and 8 week). 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 NCT03288038, 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 19 Sep 2017.