The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
- Registration Number
- NCT03288038
- Lead Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 382
- 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
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description RSV5mg + EZE 10mg Rosuvastatin Rosuvastatin 5mg/Ezetimibe 10mg RSV5mg Rosuvastatin Rosuvastatin 5mg RSV10mg + EZE10mg Rosuvastatin Rosuvastatin 10mg/ Ezetimibe 10mg RSV5mg + EZE 10mg Ezetimibe Rosuvastatin 5mg/Ezetimibe 10mg RSV10mg + EZE10mg Ezetimibe Rosuvastatin 10mg/ Ezetimibe 10mg RSV10mg Rosuvastatin Rosuvastatin 10mg RSV20mg + EZE10mg Rosuvastatin Rosuvastatin 20mg/Ezetimibe 10mg RSV20mg + EZE10mg Ezetimibe Rosuvastatin 20mg/Ezetimibe 10mg RSV20mg Rosuvastatin Rosuvastatin 20mg
- Primary Outcome Measures
Name Time Method Percent change from baseline to 8 week in LDL-Cholesterol baseline and 8 week
- Secondary Outcome Measures
Name Time Method Percent change from baseline to 4 week in LDL-Cholesterol baseline and 4 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 baseline to 4 and 8 week The change in the LDL-C level from the baseline to Week 4 and Week 8 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 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 baseline to 4 and 8 week
Trial Locations
- Locations (20)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Boramae Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of