HypercholesterolemiaPhase 4NCT00762164
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
A Phase 4 study testing Vytorin and Simvastatin in people with Hypercholesterolemia, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Vytorin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with an LDL-cholesterol greater than 100 mg/dL
- Patients willing and able to provide signed informed consent
Who cannot join
- Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- Patients intolerant of statins
- Patients receiving ezetimibe
- Patients intolerant of ezetimibe
- Patients receiving a niacin preparation
- Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
Show all 17Show fewer
- Cancer undergoing active treatment
- Creatinine clearance < 50 ml/minute
- Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
- Participation in any clinical study within the last 30 days
- Drug addition or alcohol abuse within the past 6 months
- Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
- Active use of macrolide antibiotics or verapamil
- Consumption of grapefruit juice on a daily basis
- Patients unwilling or unable to provide informed consent
- Patients with poor compliance
- Women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.
- Conditions
- Hypercholesterolemia
- Being tested
- Vytorin, Simvastatin
- Keywords
- Hypercholesterolemia, Statins, Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VytorinDrug
Vytorin 10/80 split into 4
SimvastatinDrug
Simvastatin 20 milligrams
| Study group | Role | What they receive |
|---|---|---|
| 1Vytorin 10/80 divided into 4 | Active comparator | Vytorin 10/80 divided into 4 Receives: Drug: Vytorin |
| Simvastatin | Active comparator | Simvastatin 20 milligrams Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
Measured: 6 weeks
Secondary outcomes (1)
Total Cholesterol
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lawrence Baruch, Bronx VA Medical Center
- Investigators
- Lawrence Baruch, MD, Principal investigator, Bronx VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762164
- Sponsor's protocol ID
- VA---19-07-01
- Status last verified
- Apr 2013
- First submitted
- 29 Sep 2008
- Last updated
- 3 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
- ClinicalTrials.gov ID
- NCT00762164
- Acronym / sponsor ID
- VA---19-07-01
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Statins, Ezetimibe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 3 Jul 2013
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 compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Vytorin 10/80 divided into 4 | Active comparator | Drug: VytorinVytorin 10/80 divided into 4 |
| Simvastatin | Active comparator | Drug: SimvastatinSimvastatin 20 milligrams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with an LDL-cholesterol greater than 100 mg/dL
- Patients willing and able to provide signed informed consent
Key exclusion criteria (17 listed)
- Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- Patients intolerant of statins
- Patients receiving ezetimibe
- Patients intolerant of ezetimibe
- Patients receiving a niacin preparation
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 |
|---|---|---|
| VytorinVytorin 10/80 split into 4 | Drug | 1Vytorin 10/80 divided into 4 |
| SimvastatinSimvastatin 20 milligrams | Drug | Simvastatin |
Primary outcome
LDL Cholesterol
Time frame: 6 weeks
1 secondary outcome
Total Cholesterol
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence Baruch, MD principal investigator
Bronx VA Medical Center
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 Bronx VA Medical Center at 1 site in United States.
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 2 inclusion and 17 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 3 Jul 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LDL Cholesterol (time frame: 6 weeks). 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 3 Jul 2013; AzTrials last refreshed its copy on 1 Nov 2026.