HypercholesterolemiaPhase 4NCT01666067
Vascular and Metabolic Effects of Vytorin vs Simvastatin
A Phase 4 study testing vytorin and simvastatin in people with Hypercholesterolemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- vytorin and simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Nov 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl)
Who cannot join
- overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin
- Conditions
- Hypercholesterolemia
- Being tested
- placebo, vytorin, simvastatin
- Keywords
- insulin resistance
- Medical subject headings
- Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
vytorinDrug
simvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Active comparator | placebo Receives: Drug: placebo |
| vytorin | Active comparator | vytorin Receives: Drug: vytorin |
| simvastatin | Active comparator | simvastatin Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow-mediated dilation
Measured: 8 weeks of treatment
Secondary outcomes (1)
insulin resistance
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang Kon Koh, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666067
- Sponsor's protocol ID
- GMC-201110
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular and Metabolic Effects of Vytorin vs Simvastatin
- ClinicalTrials.gov ID
- NCT01666067
- Acronym / sponsor ID
- GMC-201110
- Conditions
- Hypercholesterolemia
- Keywords
- insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Aug 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.
The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Active comparator | Drug: placeboplacebo |
| vytorin | Active comparator | Drug: vytorinvytorin |
| simvastatin | Active comparator | Drug: simvastatinsimvastatin |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl)
Key exclusion criteria (1 listed)
- overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse
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 |
|---|---|---|
| placebo | Drug | placebo |
| vytorin | Drug | vytorin |
| simvastatin | Drug | simvastatin |
Primary outcome
flow-mediated dilation
Time frame: 8 weeks of treatment
1 secondary outcome
insulin resistance
Time frame: 8 weeks of treatment
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 4 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vytorin and simvastatin in people with Hypercholesterolemia, run by Gachon University Gil Medical Center 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 1 inclusion and 1 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 4 Nov 2014. 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 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?
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?
flow-mediated dilation (time frame: 8 weeks of treatment). 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 4 Nov 2014.