Cardiovascular DiseasesPhase 3NCT00395603
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks in people with Cardiovascular Diseases and Diabetes Mellitus, run by Organon and Co.
Trial summary
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus
- What is being tested?
- MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jun 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
- Existing coronary heart disease and cholesterol > 4.0 mmol/l
Who cannot join
- Uncontrolled diabetes
- Elevated liver function tests
- Elevated creatine kinase (ck)
- Triglycerides (tg) > 4.5 mmol/l
- Drug or alcohol dependency within 6 months prior to visit 1
- Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
- Woman of childbearing potential not using an acceptable method of birth control
- Women who are pregnant or breast feeding
About this study
Official title: Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus
- Being tested
- MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks, Comparator: atorvastatin / Duration of Treatment: 6 Weeks
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 WeeksDrug
Comparator: atorvastatin / Duration of Treatment: 6 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in ldl-c at end-point after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: This study was terminated early due to poor recruitment.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395603
- Sponsor's protocol ID
- 0653A-122
- Other IDs
- 2006_042
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
- ClinicalTrials.gov ID
- NCT00395603
- Acronym / sponsor ID
- 0653A-122
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to poor recruitment.
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Nov 2006 (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.
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age
- Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
- Existing coronary heart disease and cholesterol > 4.0 mmol/l
Key exclusion criteria (8 listed)
- Uncontrolled diabetes
- Elevated liver function tests
- Elevated creatine kinase (ck)
- Triglycerides (tg) > 4.5 mmol/l
- Drug or alcohol dependency within 6 months prior to visit 1
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 |
|---|---|---|
| MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks | Drug | – |
| Comparator: atorvastatin / Duration of Treatment: 6 Weeks | Drug | – |
Primary outcome
Percentage reduction in ldl-c at end-point after 6 weeks.
Results and safety
The study was stopped early (reason given: This study was terminated early due to poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks in people with Cardiovascular Diseases and Diabetes Mellitus, run by Organon and Co.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Aug 2024. 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 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 was stopped early (reason given: This study was terminated early due to poor recruitment.). 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?
Percentage reduction in ldl-c at end-point after 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 15 Aug 2024; AzTrials last refreshed its copy on 3 Nov 2026.