The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

NCT03288038 | Completed Phase 3

• 1 other identifier: SP-RE-003
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 20

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to 8 week in LDL-Cholesterol

  baseline and 8 week

Secondary Outcomes (5)

• Percent change from baseline to 4 week in LDL-Cholesterol

  baseline and 4 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

• 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

Study Arms (6)

RSV5mg + EZE 10mg

EXPERIMENTAL

Rosuvastatin 5mg/Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

RSV5mg

ACTIVE COMPARATOR

Rosuvastatin 5mg

Drug: Rosuvastatin

RSV10mg + EZE10mg

EXPERIMENTAL

Rosuvastatin 10mg/ Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

RSV10mg

ACTIVE COMPARATOR

Rosuvastatin 10mg

Drug: Rosuvastatin

RSV20mg + EZE10mg

EXPERIMENTAL

Rosuvastatin 20mg/Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

RSV20mg

ACTIVE COMPARATOR

Rosuvastatin 20mg

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

RSV10mg; RSV10mg + EZE10mg; RSV20mg; RSV20mg + EZE10mg; RSV5mg; RSV5mg + EZE 10mg

Ezetimibe DRUG

RSV10mg + EZE10mg; RSV20mg + EZE10mg; RSV5mg + EZE 10mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (20)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Dongguk University Ilsan Hospital

Goyang-si, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Boramae Hospital

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

KyungHee University Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29857919 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: September 19, 2017
• Study Start: October 13, 2014
• Primary Completion: November 19, 2015
• Study Completion: November 19, 2015
• Last Updated: September 19, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (20)