Status:
COMPLETED
The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
Lead Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2015
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT03288038
Start Date
October 13 2014
End Date
November 19 2015
Last Update
September 19 2017
Active Locations (20)
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1
Chungbuk National University Hospital
Cheongju-si, South Korea
2
Yeungnam University Medical Center
Daegu, South Korea
3
Chungnam National University Hospital
Daejeon, South Korea
4
Dongguk University Ilsan Hospital
Goyang-si, South Korea