Clinical Trials/NCT03288038

NCT03288038

Completed

Phase 3

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

Shin Poong Pharmaceutical Co. Ltd.20 sites in 1 country382 target enrollmentOctober 13, 2014

ConditionsHypercholesterolemia

InterventionsRosuvastatin Ezetimibe

DrugsRosuvastatin Ezetimibe

Overview

Phase: Phase 3
Intervention: Rosuvastatin
Conditions: Hypercholesterolemia
Sponsor: Shin Poong Pharmaceutical Co. Ltd.
Enrollment: 382
Locations: 20
Primary Endpoint: Percent change from baseline to 8 week in LDL-Cholesterol
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 13, 2014

End Date

November 19, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

RSV20mg

Rosuvastatin 20mg

Intervention: Rosuvastatin

RSV10mg + EZE10mg

Rosuvastatin 10mg/ Ezetimibe 10mg

Intervention: Rosuvastatin

RSV20mg + EZE10mg

Rosuvastatin 20mg/Ezetimibe 10mg

Intervention: Rosuvastatin

RSV5mg + EZE 10mg

Rosuvastatin 5mg/Ezetimibe 10mg

Intervention: Rosuvastatin

RSV5mg + EZE 10mg

Rosuvastatin 5mg/Ezetimibe 10mg

Intervention: Ezetimibe

RSV5mg

Rosuvastatin 5mg

Intervention: Rosuvastatin

RSV10mg + EZE10mg

Rosuvastatin 10mg/ Ezetimibe 10mg

Intervention: Ezetimibe

RSV20mg + EZE10mg

Rosuvastatin 20mg/Ezetimibe 10mg

Intervention: Ezetimibe

RSV10mg

Rosuvastatin 10mg

Intervention: Rosuvastatin

Outcomes

Primary Outcomes

Percent change from baseline to 8 week in LDL-Cholesterol

Time Frame: baseline and 8 week

Secondary Outcomes

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 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)
The change in the LDL-C level from the baseline to Week 4 and Week 8(baseline to 4 and 8 week)