The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
NCT ID: NCT03288038
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
382 participants
INTERVENTIONAL
2014-10-13
2015-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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RSV5mg + EZE 10mg
Rosuvastatin 5mg/Ezetimibe 10mg
Rosuvastatin
Ezetimibe
RSV5mg
Rosuvastatin 5mg
Rosuvastatin
RSV10mg + EZE10mg
Rosuvastatin 10mg/ Ezetimibe 10mg
Rosuvastatin
Ezetimibe
RSV10mg
Rosuvastatin 10mg
Rosuvastatin
RSV20mg + EZE10mg
Rosuvastatin 20mg/Ezetimibe 10mg
Rosuvastatin
Ezetimibe
RSV20mg
Rosuvastatin 20mg
Rosuvastatin
Interventions
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Rosuvastatin
Ezetimibe
Eligibility Criteria
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Inclusion Criteria
2. Patients with primary hypercholesterolemia
3. 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
4. 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
Exclusion Criteria
2. Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
3. 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
4. Those with a history of malignant tumor within 5 years
5. Those with a history of myopathy or rhabdomyolysis
6. 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)
7. 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.)
8. 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.)
9. Those with a history of alcohol or drug abuse
10. Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
11. Pregnant or breast-feeding women
12. 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.)
13. 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
14. Those with drug malabsorption
15. Patients who has been judged by the investigator to be ineligible to participate in the clinical study
19 Years
ALL
No
Sponsors
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Shin Poong Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Chungbuk National University Hospital
Cheongju-si, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Dongguk University Ilsan Hospital
Goyang-si, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Boramae Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
KyungHee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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References
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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.
Other Identifiers
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SP-RE-003
Identifier Type: -
Identifier Source: org_study_id