Clinical trial NCT01564875: Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Hyperlipidemia
Keywords: Simvast CR
Zocor
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent change of LDL-C
timeFrame: 8 weeks
Secondary outcomes:
measure: Change and percent change of TC, HDL-C, TG
timeFrame: 8 weeks
measure: Accomplishment rate of therapeutic goals
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )
name: Kyung-mi Park, Ph.D
role: STUDY_DIRECTOR
References: