Efficacy and Safety of Morning Intake of Simvast Controlled Release (CR) Tablet Versus Evening Intake of Zocor Tablet in Chronic Kidney Disease Stage(CKD)3, 4 and 5 Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 4 Trial (HM-SIM4)

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

Sponsors

Lead sponsor: Hanmi Pharmaceutical Company Limited

Source Hanmi Pharmaceutical Company Limited
Brief Summary

Study design

- Multicenter, double-dummy, double-blinded, randomized, Phase 4 study

- Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs

Study Objective

-The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia

Primary objective

-to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.

Detailed Description

The secondary objectives of the study are as follows:

- to assess the change and percent change of TC, HDL-C, TG from baseline.

- to assess the accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.

Overall Status Unknown status
Start Date December 2010
Completion Date May 2012
Primary Completion Date May 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent change of LDL-C 8 weeks
Secondary Outcome
Measure Time Frame
Change and percent change of TC, HDL-C, TG 8 weeks
Accomplishment rate of therapeutic goals 8 weeks
Enrollment 122
Condition
Intervention

Intervention type: Drug

Intervention name: Simvast CR

Description: Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.

Arm group label: Simvast CR

Intervention type: Drug

Intervention name: Zocor

Description: Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.

Arm group label: Zocor

Eligibility

Criteria:

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.

Gender: All

Minimum age: 20 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kyung-mi Park, Ph.D Study Director Hanmi Pharmaceutical Company Limited ( e-mail: [email protected] )
Location
facility
Hallym University Medical Center | Anyang-si, Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital | Goyang-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Hospital | Incheon, Korea, Republic of
Eulji General Hospital | Seoul, Korea, Republic of
Hanyang University Seoul Hospital | Seoul, Korea, Republic of
Korea University Anam Hospital | Seoul, Korea, Republic of
Seoul National University Hospital | Seoul, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

March 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Simvast CR

Arm group type: Experimental

Description: Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m. Placebo with the same appearance and formulation as that of Zocor Tab, 1 tablet once daily to be administered between 6 and 9 p.m.

Arm group label: Zocor

Arm group type: Active Comparator

Description: Placebo with the same appearance and formulation as that of Simvast CR Tab, 1 tablet once daily to be administered between 6 and 9 a.m. Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.

Acronym HM-SIM4
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov