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)

March 26, 2012 updated by: Hanmi Pharmaceutical Company Limited

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Eulji General Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Hanyang University Seoul Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of
        • Hallym University Medical Center
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Inje University Ilsan Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simvast CR
  • 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.
Drug: Simvast CR
Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
ACTIVE_COMPARATOR: Zocor
  • 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.
Drug: Zocor
Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change of LDL-C
Time Frame: 8 weeks
Percent change of LDL-C at Week 8 from baseline
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change and percent change of TC, HDL-C, TG
Time Frame: 8 weeks
Change and percent change of TC, HDL-C, TG from baseline.
8 weeks
Accomplishment rate of therapeutic goals
Time Frame: 8 weeks
-Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Study Director: Kyung-mi Park, Ph.D, Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-SIM4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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