HypercholesterolemiaPhase 3NCT00409773

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

A Phase 3 study testing ezetimibe (+) simvastatin and Comparator: atorvastatin calcium in people with Hypercholesterolemia and Metabolic Syndrome, 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

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypercholesterolemia, Metabolic Syndrome
What is being tested?: ezetimibe (+) simvastatin and Comparator: atorvastatin calcium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,143 participants
Where: No sites listed yet
Study dates: Jan 2007to Jul 2008
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

Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Who cannot join

A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
Patient is likely to be greater than 20% noncompliant in taking study medications
Patients with chronic medical conditions
Patients with unstable doses of medications
Pregnant or lactating women, women intending to become pregnant
Patient is currently receiving prescription therapy with statins or other lipid-altering medications
Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

Conditions: Hypercholesterolemia, Metabolic Syndrome
Being tested: ezetimibe (+) simvastatin, Comparator: atorvastatin calcium, Comparator: Placebo (unspecified)
Medical subject headings: Hypercholesterolemia, Metabolic Syndrome

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®
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Comparator: atorvastatin calciumDrug
Also called Lipitor ®
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Comparator: Placebo (unspecified)Drug
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Study groups in NCT00409773
Study group	Role	What they receive
1	Other	Arm 1: drug + comparator + Placebo Receives: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)
2	Other	Arm 2: drug + comparator + Placebo Receives: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)
3	Other	Arm 3: drug + comparator + Placebo Receives: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)
4	Other	Arm 4: drug + comparator + Placebo Receives: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)
5	Other	Arm 5: drug + comparator + Placebo Receives: Drug: ezetimibe (+) simvastatin; Drug: Comparator: atorvastatin calcium; Drug: Comparator: Placebo (unspecified)

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 (LDL-C) at Week 6
Measured: Baseline and 6 Weeks

Secondary outcomes (14)

Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Measured: Baseline and 6 weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Measured: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Measured: Baseline and 6 Weeks
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Measured: Baseline and 6 Weeks

Timeline

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

Jan 2007Jul 2008

First posted11 Dec 2006 (estimated)
Study startJan 2007
Primary completionJul 2008
Study completionJul 2008

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 (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00409773
Sponsor's protocol ID: 0653A-107
Other IDs: 2006_527
Status last verified: Feb 2022
First submitted: 8 Dec 2006
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
PubMed 26336957
Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
PubMed 22108151

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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

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 Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
ClinicalTrials.gov ID: NCT00409773
Acronym / sponsor ID: 0653A-107
Conditions: Hypercholesterolemia, Metabolic Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,143 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 11 Dec 2006 (estimated)
Results: Posted 4 Aug 2009

Clinical summary

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

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
1	Other	Drug: ezetimibe (+) simvastatin, Drug: Comparator: atorvastatin calcium, Drug: Comparator: Placebo (unspecified)Arm 1: drug + comparator + Placebo
2	Other	Drug: ezetimibe (+) simvastatin, Drug: Comparator: atorvastatin calcium, Drug: Comparator: Placebo (unspecified)Arm 2: drug + comparator + Placebo
3	Other	Drug: ezetimibe (+) simvastatin, Drug: Comparator: atorvastatin calcium, Drug: Comparator: Placebo (unspecified)Arm 3: drug + comparator + Placebo
4	Other	Drug: ezetimibe (+) simvastatin, Drug: Comparator: atorvastatin calcium, Drug: Comparator: Placebo (unspecified)Arm 4: drug + comparator + Placebo
5	Other	Drug: ezetimibe (+) simvastatin, Drug: Comparator: atorvastatin calcium, Drug: Comparator: Placebo (unspecified)Arm 5: drug + comparator + Placebo

Who may qualify

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

Key inclusion criteria (1 listed)

Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Key exclusion criteria (7 listed)

A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
Patient is likely to be greater than 20% noncompliant in taking study medications
Patients with chronic medical conditions
Patients with unstable doses of medications
Pregnant or lactating women, women intending to become pregnant

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, Vytorin®Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.	Drug	1, 2, 3, 4, 5
Comparator: atorvastatin calciumAlso: Lipitor ®Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.	Drug	1, 2, 3, 4, 5
Comparator: Placebo (unspecified)Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.	Drug	1, 2, 3, 4, 5

Primary outcome

Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Time frame: Baseline and 6 Weeks

14 secondary outcomes

Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Time frame: Baseline and 6 weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Time frame: Baseline and 6 Weeks
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Time frame: Baseline and 6 Weeks

Results and safety

Results posted to the registry on 4 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorva 10 mg	229	220
EZ/Simva 10 mg/20 mg	229	222
Atorva 20mg	229	220
EZ/Simva 10 mg/40 mg	228	216
Atorva 40 mg	228	218

Primary outcome: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6

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

Measure	Atorva 10 mg n = 215	EZ/Simva 10 mg/20 mg n = 219	Atorva 20mg n = 215	EZ/Simva 10 mg/40 mg n = 217	Atorva 40 mg n = 217
Value	-36.5 (-38.9 to -34.0)	-49.6 (-52.0 to -47.2)	-39.4 (-41.8 to -36.9)	-53.9 (-56.4 to -51.5)	-46.0 (-48.4 to -43.6)

Atorva 10 mg vs EZ/Simva 10 mg/20 mg: Mean Difference (Final Values): -13.1 (95% CI -16.5 to -9.8), p <0.001, ANOVA
EZ/Simva 10 mg/20 mg vs Atorva 20mg: Mean Difference (Final Values): -10.2 (95% CI -13.6 to -6.9), p <0.001, ANOVA
EZ/Simva 10 mg/40 mg vs Atorva 40 mg: Mean Difference (Final Values): -8.0 (95% CI -11.3 to -4.6), p <0.001, ANOVA

Population analysed: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorva 10 mg	4 of ?	21 of ?	Not reported
EZ/Simva 10 mg/20 mg	0 of ?	14 of ?	Not reported
Atorva 20mg	1 of ?	22 of ?	Not reported
EZ/Simva 10 mg/40 mg	1 of ?	13 of ?	Not reported
Atorva 40 mg	4 of ?	13 of ?	Not reported

Limitations and caveats (from the sponsor): 15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.

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 26336957Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
Derived from this study: PubMed 22108151Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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 and Comparator: atorvastatin calcium in people with Hypercholesterolemia and Metabolic Syndrome, 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 1 inclusion and 7 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 4 Aug 2009). 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 (LDL-C) at Week 6 (time frame: Baseline and 6 Weeks). 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 NCT00409773, which also lists 2 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.