Cardiovascular DisorderPhase 3NCT00862251

Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

A Phase 3 study testing ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg and Rosuvastatin in people with Cardiovascular Disorder and Diabetes Mellitus, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or… Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Cardiovascular Disorder, Diabetes Mellitus
What is being tested?: ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg and Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 808 participants
Where: No sites listed yet
Study dates: Apr 2009to Mar 2011
Phase: Phase 3
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 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
Patient is willing to remain abstinent or use birth control for the duration of the study
Patient has Diabetes Mellitus with cardiovascular disease

Who cannot join

Patient has sensitivity to certain common statin drugs
Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
Patient consumes more than 2 alcoholic drinks per day
Patient is pregnant or breast-feeding
Patient has been treated with other investigational drugs within 30 days of first visit
Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin

Show all 16Show fewer

Patient has congestive heart failure
Patient has uncontrolled high blood pressure
Patient has kidney disease
Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
Patient has diabetes mellitus that is not well controlled
Patient is human immunodeficiency virus (HIV) positive
Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
Patient is currently taking therapies that would increase the risk of muscle weakness
Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
Patient is currently taking psyllium or other fiber-based laxatives

About this study

Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose

Conditions: Cardiovascular Disorder, Diabetes Mellitus
Being tested: ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg, Rosuvastatin, atorvastatin 10 mg or simvastatin 20 mg
Keywords: cardiovascular disorder
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.

ezetimibe (+) simvastatinDrug
Also called Vytorin
ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
simvastatin 40 mg or atorvastatin 20 mgDrug
Also called Lipitor, Zocor
simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
RosuvastatinDrug
Also called Crestor
rosuvastatin 10 mg tablets, taken once daily for six weeks.
atorvastatin 10 mg or simvastatin 20 mgDrug
Also called Lipitor, Zocor
All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Study groups in NCT00862251
Study group	Role	What they receive
Ezetimibe/simvastatin	Experimental	Not described Receives: Drug: ezetimibe (+) simvastatin; Drug: atorvastatin 10 mg or simvastatin 20 mg
Doubling statin dose	Active comparator	Not described Receives: Drug: simvastatin 40 mg or atorvastatin 20 mg; Drug: atorvastatin 10 mg or simvastatin 20 mg
Rosuvastatin	Active comparator	Not described Receives: Drug: Rosuvastatin; Drug: atorvastatin 10 mg or simvastatin 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).
Measured: Baseline and Week 6

Secondary outcomes (17)

In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin
Measured: Baseline and Week 6
In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin
Measured: Baseline and Week 6
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
Measured: Baseline and Week 6
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Measured: Week 6
In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Measured: Week 6
In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Measured: Week 6
Percent Change From Baseline in Total Cholesterol (TC)
Measured: Baseline and Week 6
Percent Change From Baseline in Triglycerides
Measured: Baseline and Week 6
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Measured: Baseline and Week 6
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Measured: Baseline and Week 6
Percent Change From Baseline in LDL-C/HDL-C Ratio
Measured: Baseline and Week 6
Percent Change From Baseline in TC/HDL-C Ratio
Measured: Baseline and Week 6
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio
Measured: Baseline and Week 6
Percent Change From Baseline in Apolipoprotein B (Apo B)
Measured: Baseline and Week 6
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)
Measured: Baseline and Week 6
Percent Change From Baseline in Apo B/Apo A-I Ratio
Measured: Baseline and Week 6
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Mar 2011

First posted16 Mar 2009 (estimated)
Study startApr 2009
Primary completionMar 2011
Study completionMar 2011

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DisorderStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 808 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00862251
Sponsor's protocol ID: 0653A-133
Other IDs: 2009_559
Status last verified: Feb 2022
First submitted: 12 Mar 2009
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Le NA, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Effect of Switching From Statin Monotherapy to Ezetimibe/Simvastatin Combination Therapy Compared With Other Intensified Lipid-Lowering Strategies on Lipoprotein Subclasses in Diabetic Patients With Symptomatic Cardiovascular Disease. J Am Heart Assoc. 2015 Oct 20;4(10):e001675. doi: 10.1161/JAHA.114.001675.
PubMed 26486166
Rosen JB, Jimenez JG, Pirags V, Vides H, Massaad R, Hanson ME, Brudi P, Triscari J. Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects. Lipids Health Dis. 2013 Jul 16;12:103. doi: 10.1186/1476-511X-12-103.
PubMed 23866306
Rosen JB, Jimenez JG, Pirags V, Vides H, Hanson ME, Massaad R, McPeters G, Brudi P, Triscari J. A comparison of efficacy and safety of an ezetimibe/simvastatin combination compared with other intensified lipid-lowering treatment strategies in diabetic patients with symptomatic cardiovascular disease. Diab Vasc Dis Res. 2013 May;10(3):277-86. doi: 10.1177/1479164112465212. Epub 2013 Jan 3.
PubMed 23288881
Jimenez JG, Rosen JB, Pirags V, Massaad R, Hanson ME, Brudi P, Triscari J. The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome. Diabetes Obes Metab. 2013 Jun;15(6):513-22. doi: 10.1111/dom.12059. Epub 2013 Jan 25.
PubMed 23279632

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose
ClinicalTrials.gov ID: NCT00862251
Acronym / sponsor ID: 0653A-133
Conditions: Cardiovascular Disorder, Diabetes Mellitus
Keywords: cardiovascular disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 808 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 16 Mar 2009 (estimated)
Results: Posted 16 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ezetimibe/simvastatin	Experimental	Drug: ezetimibe (+) simvastatin, Drug: atorvastatin 10 mg or simvastatin 20 mg
Doubling statin dose	Active comparator	Drug: simvastatin 40 mg or atorvastatin 20 mg, Drug: atorvastatin 10 mg or simvastatin 20 mg
Rosuvastatin	Active comparator	Drug: Rosuvastatin, Drug: atorvastatin 10 mg or simvastatin 20 mg

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
Patient is willing to remain abstinent or use birth control for the duration of the study
Patient has Diabetes Mellitus with cardiovascular disease

Key exclusion criteria (16 listed)

Patient has sensitivity to certain common statin drugs
Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
Patient consumes more than 2 alcoholic drinks per day
Patient is pregnant or breast-feeding
Patient has been treated with other investigational drugs within 30 days of first visit

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: Vytorinezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.	Drug	Ezetimibe/simvastatin
simvastatin 40 mg or atorvastatin 20 mgAlso: Lipitor, Zocorsimvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.	Drug	Doubling statin dose
RosuvastatinAlso: Crestorrosuvastatin 10 mg tablets, taken once daily for six weeks.	Drug	Rosuvastatin
atorvastatin 10 mg or simvastatin 20 mgAlso: Lipitor, ZocorAll patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.	Drug	Doubling statin dose, Ezetimibe/simvastatin, Rosuvastatin

Primary outcome

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).
Time frame: Baseline and Week 6

17 secondary outcomes

In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin
Time frame: Baseline and Week 6
In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin
Time frame: Baseline and Week 6
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
Time frame: Baseline and Week 6
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame: Week 6
In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame: Week 6
In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame: Week 6
Percent Change From Baseline in Total Cholesterol (TC)
Time frame: Baseline and Week 6
Percent Change From Baseline in Triglycerides
Time frame: Baseline and Week 6
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Week 6
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: Baseline and Week 6
Percent Change From Baseline in LDL-C/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in TC/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time frame: Baseline and Week 6
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)
Time frame: Baseline and Week 6
Percent Change From Baseline in Apo B/Apo A-I Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline and Week 6

Results and safety

Results posted to the registry on 16 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe/Simvastatin	322	303
Doubling Statin Dose	162	157
Rosuvastatin	324	315

Primary outcome: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: Percent change

Measure	Ezetimibe/Simvastatin n = 314	Doubling Statin Dose n = 159
Value	-23.13 (-25.95 to -20.31)	-8.37 (-12.32 to -4.41)

Ezetimibe/Simvastatin vs Doubling Statin Dose: Percent change in least-square means: -14.76 (95% CI -19.61 to -9.91), p <0.001, Longitudinal data analysis (LDA)

Population analysed: Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe/Simvastatin	2 of 321 (0.6%)	0 of 321 (0%)	Not reported
Doubling Statin Dose	1 of 162 (0.6%)	0 of 162 (0%)	Not reported
Rosuvastatin	2 of 323 (0.6%)	0 of 323 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26486166Le NA, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Effect of Switching From Statin Monotherapy to Ezetimibe/Simvastatin Combination Therapy Compared With Other Intensified Lipid-Lowering Strategies on Lipoprotein Subclasses in Diabetic Patients With Symptomatic Cardiovascular Disease. J Am Heart Assoc. 2015 Oct 20;4(10):e001675. doi: 10.1161/JAHA.114.001675.
Derived from this study: PubMed 23866306Rosen JB, Jimenez JG, Pirags V, Vides H, Massaad R, Hanson ME, Brudi P, Triscari J. Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects. Lipids Health Dis. 2013 Jul 16;12:103. doi: 10.1186/1476-511X-12-103.
Derived from this study: PubMed 23288881Rosen JB, Jimenez JG, Pirags V, Vides H, Hanson ME, Massaad R, McPeters G, Brudi P, Triscari J. A comparison of efficacy and safety of an ezetimibe/simvastatin combination compared with other intensified lipid-lowering treatment strategies in diabetic patients with symptomatic cardiovascular disease. Diab Vasc Dis Res. 2013 May;10(3):277-86. doi: 10.1177/1479164112465212. Epub 2013 Jan 3.
Derived from this study: PubMed 23279632Jimenez JG, Rosen JB, Pirags V, Massaad R, Hanson ME, Brudi P, Triscari J. The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome. Diabetes Obes Metab. 2013 Jun;15(6):513-22. doi: 10.1111/dom.12059. Epub 2013 Jan 25.
Individual participant dataSharing planned: No

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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 ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg and Rosuvastatin in people with Cardiovascular Disorder 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 4 inclusion and 16 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 16 May 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?

Yes. Results are posted in the registry (first posted 16 Mar 2012). 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?

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00862251, which also lists 4 linked publications.

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 16 May 2024.