Cardiovascular DiseasesPhase 4VYCTORNCT00738296
Vytorin on Carotid Intima-media Thickness and Overall Rigidity
A Phase 4 study testing ezetimibe (+) simvastatin, simvastatin and pravastatin in people with Cardiovascular Diseases, run by Hospital Universitario 12 de Octubre.
Trial summary
Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- ezetimibe (+) simvastatin, simvastatin and pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2005
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ldl-C Levels >100 Mg/Dl
- Patients Who Have Signed The Consent
- Patients Of ages between 30 and 75 Years Old
- Patients Of Both Genders
- Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease
- Patients Without Previous Treatment With Ezetimibe
Who cannot join
None listed.
About this study
Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.
- Conditions
- Cardiovascular Diseases
- Being tested
- ezetimibe (+) simvastatin, simvastatin, pravastatin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibe (+) simvastatinDrug
Also called MK0653A, Vytorin
Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets
simvastatinDrug
Also called Zocor
Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets
pravastatinDrug
Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Group A: Comparator Receives: Drug: simvastatin |
| B | Active comparator | Group B: Comparator Receives: Drug: pravastatin |
| C | Experimental | Group C: Drug Receives: Drug: ezetimibe (+) simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The annual progression of the slope of the maximum average GIM and the arterial rigidity.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startApr 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Alejandra Meaney Martinez, Hospital Universitario 12 de Octubre
- Investigators
- Alejandra Meaney, MD, PhD, Principal investigator, Hospital Regional 1o de Octubre, ISSSTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738296
- Sponsor's protocol ID
- 2008_018
- Other IDs
- MK0653A-164
- Acronym
- VYCTOR
- Status last verified
- Aug 2008
- First submitted
- 18 Aug 2008
- Last updated
- 24 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vytorin on Carotid Intima-media Thickness and Overall Rigidity
- ClinicalTrials.gov ID
- NCT00738296
- Acronym / sponsor ID
- VYCTOR / 2008_018
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Aug 2008 (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.
Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: simvastatinGroup A: Comparator |
| B | Active comparator | Drug: pravastatinGroup B: Comparator |
| C | Experimental | Drug: ezetimibe (+) simvastatinGroup C: Drug |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ldl-C Levels >100 Mg/Dl
- Patients Who Have Signed The Consent
- Patients Of ages between 30 and 75 Years Old
- Patients Of Both Genders
- Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ezetimibe (+) simvastatinAlso: MK0653A, VytorinPatients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets | Drug | C |
| simvastatinAlso: ZocorPatients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets | Drug | A |
| pravastatinPatients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets | Drug | B |
Primary outcome
The annual progression of the slope of the maximum average GIM and the arterial rigidity.
Time frame: 1 Year
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 24 Jun 2015.
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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.
Alejandra Meaney, MD, PhD principal investigator
Hospital Regional 1o de Octubre, ISSSTE
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezetimibe (+) simvastatin, simvastatin and pravastatin in people with Cardiovascular Diseases, run by Hospital Universitario 12 de Octubre.
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 6 inclusion and 0 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The annual progression of the slope of the maximum average GIM and the arterial rigidity. (time frame: 1 Year). 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 24 Jun 2015.