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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Chronic Kidney Disease Hyperlipidemia
Intervention	Drug: Simvast CR Drug: Zocor
Phase	Phase 4
Sponsor	Hanmi Pharmaceutical Company Limited
Responsible Party	Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier	NCT01564875
First Received	March 23, 2012
Last Updated	March 26, 2012
Last verified	March 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 23, 2012
Last Updated Date	March 26, 2012
Start Date	December 2010
Estimated Primary Completion Date	May 2012
Current Primary Outcome Measures	Percent change of LDL-C [Time Frame: 8 weeks] [Designated as safety issue: Yes]Percent change of LDL-C at Week 8 from baseline
Current Secondary Outcome Measures	Change and percent change of TC, HDL-C, TG [Time Frame: 8 weeks] [Designated as safety issue: Yes]Change and percent change of TC, HDL-C, TG from baseline. Accomplishment rate of therapeutic goals [Time Frame: 8 weeks] [Designated as safety issue: Yes]-Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.

Descriptive Information[ + expand ][ + ]

Brief Title	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)
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Chronic Kidney Disease Hyperlipidemia
Intervention	Drug: Simvast CR Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m. Drug: Zocor Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.
Study Arm (s)	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. 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	122
Estimated Completion Date	May 2012
Estimated Primary Completion Date	May 2012
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	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01564875
Other Study ID Numbers	HM-SIM4
Has Data Monitoring Committee	No
Information Provided By	Hanmi Pharmaceutical Company Limited
Study Sponsor	Hanmi Pharmaceutical Company Limited
Collaborators	Not Provided
Investigators	Study Director: Kyung-mi Park, Ph.D Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )
Verification Date	March 2012

Locations[ + expand ][ + ]

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
Seoul National University Hospital	Seoul, Korea, Republic of
Korea University Anam Hospital	Seoul, Korea, Republic of
Eulji General Hospital	Seoul, Korea, Republic of
Hanyang University Seoul Hospital	Seoul, Korea, Republic of