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

NCT01564875 | Unknown Phase 4

• 1 other identifier: HM-SIM4
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Kidney Disease; Hyperlipidemia

Keywords

Simvast CR; Zocor

Outcome Measures

Primary Outcomes (1)

• Percent change of LDL-C

  Percent change of LDL-C at Week 8 from baseline

  8 weeks

Secondary Outcomes (2)

• Change and percent change of TC, HDL-C, TG

  8 weeks

• Accomplishment rate of therapeutic goals

  8 weeks

Study Arms (2)

Simvast CR

EXPERIMENTAL

* 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

Zocor

ACTIVE COMPARATOR

* 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

Interventions

Simvast CR DRUG

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

Simvast CR

Zocor DRUG

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

Zocor

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (7)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  PMID: 38018702 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperlipidemias

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Kyung-mi Park, Ph.D

  Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 28, 2012
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

KR (7)