HyperlipidemiaPhase 3NCT00973115
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
A Phase 3 study testing Simvastatin CR in people with Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Simvastatin CR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Aug 2009
- Phase
- Phase 3
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 75
- Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
- Need drug therapy by NCEP ATP III guideline
- Signed informed consent
Who cannot join
- Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
- Has a presence or history of alcohol abuse or drug abuse
- Active gallbladder disease within 12 months
- Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
- HbA1c≥ 9% in type 2 diabetes mellitus patients
- SBP < 90mmHg or > 160mmHg
Show all 19Show fewer
- DBP < 50mmHg or > 100mmHg
- Myocardial infarction or revascularization procedure within 6 months
- Has significant cardiovascular disease
- Malignant tumor within 5years
- Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
- Uric acid level > 9 mg/dl
- Thyroid stimulating hormone ≥ 2XUNL
- Active peptic ulcer disease
- CPK levels > 3XUNL
- creatinine level > 2 mg/dl
- Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
- Had participated other clinical trial within 4 weeks
- Need systemic administration of corticosteroids intermittently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial
The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.
- Conditions
- Hyperlipidemia
- Being tested
- Simvastatin CR
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin CRDrug
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin CR 20mg- morning administration | Experimental | Not described Receives: Drug: Simvastatin CR |
| Simvastatin CR 20mg- evening administration | Active comparator | Not described Receives: Drug: Simvastatin CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change from baseline in LDL cholesterol
Measured: week 8
Secondary outcomes (1)
the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seong-Hoon Park, M.D., Ph.D, Principal investigator, Ehwa Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973115
- Sponsor's protocol ID
- HM-SIM-302
- Status last verified
- Oct 2016
- First submitted
- 6 Sep 2009
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial
- ClinicalTrials.gov ID
- NCT00973115
- Acronym / sponsor ID
- HM-SIM-302
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Sep 2009 (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.
The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin CR 20mg- morning administration | Experimental | Drug: Simvastatin CR |
| Simvastatin CR 20mg- evening administration | Active comparator | Drug: Simvastatin CR |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 19 and 75
- Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
- Need drug therapy by NCEP ATP III guideline
- Signed informed consent
Key exclusion criteria (19 listed)
- Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
- Has a presence or history of alcohol abuse or drug abuse
- Active gallbladder disease within 12 months
- Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
- HbA1c≥ 9% in type 2 diabetes mellitus patients
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 |
|---|---|---|
| Simvastatin CR | Drug | Simvastatin CR 20mg- evening administration, Simvastatin CR 20mg- morning administration |
Primary outcome
the percent change from baseline in LDL cholesterol
Time frame: week 8
1 secondary outcome
the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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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.
Seong-Hoon Park, M.D., Ph.D principal investigator
Ehwa Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin CR in people with Hyperlipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site 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 4 inclusion and 19 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: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the percent change from baseline in LDL cholesterol (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2016.