Chronic Kidney DiseasePhase 4HM-SIM4NCT01564875
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
A Phase 4 study testing Simvast CR and Zocor in people with Chronic Kidney Disease and Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Hyperlipidemia
- What is being tested?
- Simvast CR and Zocor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Dec 2010to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 %).
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Hallym University Medical Center
Anyang-si, Gyeonggi-do
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
Gachon University Gil Hospital
Incheon
Eulji General Hospital
Seoul
Hanyang University Seoul Hospital
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
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 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Hyperlipidemia
- Being tested
- Simvast CR, Zocor
- Keywords
- Simvast CR, Zocor
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvast CRDrug
Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
ZocorDrug
Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Zocor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of LDL-C
Percent change of LDL-C at Week 8 from baseline
Measured: 8 weeks
Secondary outcomes (2)
Change and percent change of TC, HDL-C, TG
Change and percent change of TC, HDL-C, TG from baseline.
Measured: 8 weeks
Accomplishment rate of therapeutic goals
-Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startDec 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-mi Park, Ph.D, Study director, Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564875
- Sponsor's protocol ID
- HM-SIM4
- Acronym
- HM-SIM4
- Status last verified
- Mar 2012
- First submitted
- 23 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38018702
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01564875
- Acronym / sponsor ID
- HM-SIM4 / HM-SIM4
- Conditions
- Chronic Kidney Disease, Hyperlipidemia
- Keywords
- Simvast CR, Zocor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvast CR | Experimental | Drug: 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. |
| Zocor | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with age of 20 to 75 (inclusive)
- Patients with fasting serum lipid panels meeting the followings:
- 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.
Key exclusion criteria (25 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvast CRSimvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m. | Drug | Simvast CR |
| ZocorZocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m. | Drug | Zocor |
Primary outcome
Percent change of LDL-C
Time frame: 8 weeks
Percent change of LDL-C at Week 8 from baseline
2 secondary outcomes
Change and percent change of TC, HDL-C, TG
Time frame: 8 weeks
Accomplishment rate of therapeutic goals
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Derived from this study: PubMed 38018702Tunnicliffe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-mi Park, Ph.D study director
Hanmi Pharmaceutical Company Limited ( e-mail: kmpark@hanmi.co.kr )
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvast CR and Zocor in people with Chronic Kidney Disease and Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of LDL-C (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2012.