Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia (HM-SIM4)

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Simvast CR, Zocor Read More

Inclusion criteria:

• Patient with age of 20 to 75 (inclusive)

• Patients with fasting serum lipid panels meeting the followings:

  • At Visit 1 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL However, if the patient has been treated with antihyperlipidemics for 4 consecutive weeks or longer at the time of screening, it should be 100mg/ dL ≤ LDL-C < 160 mg/dL.
  • At Visit 2 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL
• Patients with CKD stage 3 to 5.
• Subjects considered requiring medication by the principal investigator based on the therapeutic -guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
• Patients who understand the study procedures and signed the informed consent form.

Exclusion criteria:

• Patients with a hypersensitivity to HMG-CoA reductase inhibitor or any of its ingredients.
• Patients who consume more than 14 units of alcohol a week, who are considered to have a history of drug overdose within 12 months of screening by the investigator, or who abuse other drugs.

• Patients with the following history:

  • Active gallbladder disease within 12 months of screening (patients who had cholecystectomy are eligible for the study).
  • Pancreatitis or liver disease (AST or ALT > 2 times the upper limit of the normal range at Visits 1 and 2).
  • Patients with uncontrolled diabetes mellitus (HbA1c ≥ 9.0 %).
  • Patients with hypotension (systolic blood pressure< 90mmHg or diastolic blood pressure<50mmHg).
  • Patients with uncontrolled hypertension: mean systolic blood pressure (SBP)> 160mmHg or mean diastolic blood pressure (DBP) > 100mmHg at Visit 2.
  • Patients with myocardial infarction or who had coronary artery bypass or angioplasty within 6 months before screening.
  • Patients who had stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within 6 months of screening.
  • Patients who had been treated for carotid artery disease, peripheral artery disease, or abdominal aortic aneurysm.
  • Patients with serious heart disease (patients with NYHA class (Attachment 4) III or IV congestive heart failure, unstable angina pectoris, or acute myocardial infarction).
  • Patients who were diagnosed with malignancy within 5 years or who have active tumors.
  • Patients with fibromyalgia, myopathy, rhadomyolysis, or sudden muscle pain, or patients who experienced adverse events during the previous treatment with statins.
  • Patients with mental illnesses considered by the investigator serious enough to adversely affect the patients' participation in the study.
  • Patients with uncontrolled primary hypothyroidism.
  • Patients with active peptic ulcer disease.
  • Patients with gastrointestinal conditions that may restrict drug absorptions, such as chronic diarrhea, inflammatory colic disease, partial ileal bypass, gastrorrhaphy, or gastric banding.
  • Screening CPK level > 3 times the upper limit of the normal range.
  • Patients on immunosuppressives after kidney transplantation.
  • Patients who need to be on immunosuppressives for other reasons.
• Patients who have participated in another clinical trial within the last 4 weeks of screening (except those who participated in clinical trials including observational studies that do not involve interventions such as medication).
• Pregnant women, lactating women, or women of childbearing potential who do not use appropriate contraceptives.
• Patients currently on dialysis.
• Other patients considered ineligible by the principal investigator and investigators.