Impact on hyperglycemia and lipid reduction with rouvastatin/ezetimibe versus rosuvastatinhaving similar potency in non-diabetic dyslipidemic patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007278

Enrollment

Registered

2022-05-13

Start date

2019-10-16

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The arbitration drug is composed of Rosuvastatin / ezetimibe 5mg / 10mg components as cregetjon 10 / 5mg (trade name), and these drugs are primary hypercholesterolemia (heterozygous family type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over 19 years of age 2. Hyperlipidemic patients requiring statin treatment 1) Patients with coronary artery disease or cerebral infarction but with LDL-C> 70 mg / dL 2) When LDL-C> 190 mg / dL 3) Carotid a while LDL-C> 130 mg / dL. Atherosclerosis or hs-CRP> 2ng / dL or CACS score> 100 or higher 4) LDL-C> 160 mg / dL, HDL <40 mg / dL, smoking, hypertension, male 45 years or older, female 55 years or older, family history 5) If you have stunt insertion surgery for coronary artery disease 3. Patients who voluntarily signed a research agreement

Exclusion criteria

Exclusion criteria: 1. Patients with hypersensitivity reactions to the main components (rosuvastatin, ezetimibe) or constituents 2. Patients with active liver disease or patients with consistently high symptoms of unknown cause for serum transaminase levels 3. Patients with muscle disease 4. Patients receiving cyclosporine in combination 5. creatinine clearance (CLcr)<30mL/min 6. Pregnant or potentially pregnant women and lactating women 7. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 8. Those who are taking or are expected to take drugs that affect glucose metabolism and lipid concentration, such as systemic steroids and obesity drugs. 9. Type 2 diabetic patients receiving oral glycemic enhancers and insulin treatmentv 10. Severe deterioration of liver function (more than 5 times normal for AST / ALT)

Design outcomes

Primary

Measure	Time frame
LDL-C concentration difference	—

Secondary

Measure	Time frame
HbA1c concentration difference;Lipid profile difference;fasting glucose level;insulin level;hs-crp level	—

Countries

Korea, Republic of

Contacts

Public ContactJin park

Pusan National University Hospital

dr.jinsup@gmail.com+82-51-240-7944

Outcome results