HypercholesterolemiaPhase 3NCT00535405

A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

A Phase 3 study testing Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg and Atorvastatin 20 mg in people with Hypercholesterolemia, 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 multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg and Atorvastatin 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,289 participants
Where: No sites listed yet
Study dates: Nov 2007to Mar 2009
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patient has a cholesterol level of 130 mg/dL or greater
Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Who cannot join

Patient weighs less than 100 lbs
Patient has an allergy to ezetimibe, simvastatin or atorvastatin

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

Conditions: Hypercholesterolemia
Being tested: Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg, Atorvastatin 20 mg, Ezetimibe 10 mg/simvastatin 40 mg, Atorvastatin 40 mg
Keywords: High Cholesterol
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin 10 mgDrug
Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Ezetimibe 10 mg/simvastatin 20 mgDrug
Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
Atorvastatin 20 mgDrug
Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Ezetimibe 10 mg/simvastatin 40 mgDrug
Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
Atorvastatin 40 mgDrug
Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Study groups in NCT00535405
Study group	Role	What they receive
1	Experimental	Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. Receives: Drug: Atorvastatin 10 mg
2	Experimental	Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. Receives: Drug: Ezetimibe 10 mg/simvastatin 20 mg
3	Experimental	Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. Receives: Drug: Atorvastatin 20 mg
4	Experimental	Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. Receives: Drug: Ezetimibe 10 mg/simvastatin 40 mg
5	Experimental	Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. Receives: Drug: Atorvastatin 40 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 (LDL-C) at Week 12
Measured: Baseline and 12 weeks

Secondary outcomes (5)

Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
Measured: 12 weeks
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
Measured: 12 Weeks
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
Measured: 12 Weeks
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
Measured: 12 Weeks
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
Measured: 12 Weeks

Timeline

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

Nov 2007Mar 2009

First posted26 Sep 2007 (estimated)
Study startNov 2007
Primary completionMar 2009
Study completionMar 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.
Publications (1)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: 1,289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00535405
Sponsor's protocol ID: 0653A-128
Other IDs: 2007_588
Status last verified: Feb 2022
First submitted: 25 Sep 2007
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.
PubMed 21029821

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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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingObservational study
Causes and Natural History of Dyslipidemias
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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, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease
ClinicalTrials.gov ID: NCT00535405
Acronym / sponsor ID: 0653A-128
Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,289 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Merck Shering-Plough JV Study
Study start: Nov 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 26 Sep 2007 (estimated)
Results: Posted 25 May 2010

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: 5

Arm	Type	Receives
1	Experimental	Drug: Atorvastatin 10 mgEach patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
2	Experimental	Drug: Ezetimibe 10 mg/simvastatin 20 mgEach patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
3	Experimental	Drug: Atorvastatin 20 mgEach patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
4	Experimental	Drug: Ezetimibe 10 mg/simvastatin 40 mgEach patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
5	Experimental	Drug: Atorvastatin 40 mgEach patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Patient has a cholesterol level of 130 mg/dL or greater
Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Key exclusion criteria (2 listed)

Patient weighs less than 100 lbs
Patient has an allergy to ezetimibe, simvastatin or atorvastatin

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
Atorvastatin 10 mgAtorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks	Drug	1
Ezetimibe 10 mg/simvastatin 20 mgEzetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks	Drug	2
Atorvastatin 20 mgAtorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks	Drug	3
Ezetimibe 10 mg/simvastatin 40 mgEzetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks	Drug	4
Atorvastatin 40 mgAtorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks	Drug	5

Primary outcome

Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Time frame: Baseline and 12 weeks

5 secondary outcomes

Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
Time frame: 12 weeks
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Time frame: 12 Weeks
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
Time frame: 12 Weeks
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
Time frame: 12 Weeks
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 25 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin 10 mg	257	240
Ezetimibe 10 mg/Simvastatin 20 mg	259	233
Atorvastatin 20 mg	259	241
Ezetimibe 10 mg/Simvastatin 40 mg	257	235
Atorva 40 mg	257	241

Primary outcome: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

Time frame: Baseline and 12 weeks. Least squares mean (95% Confidence Interval). Unit: Percent change in LDL-C

Measure	Atorvastatin 10 mg n = 242	Ezetimibe 10 mg/Simvastatin 20 mg n = 232	Atorvastatin 20 mg n = 238	Ezetimibe 10 mg/Simvastatin 40 mg n = 236	Atorva 40 mg n = 239
Value	-39.5 (-41.4 to -37.5)	-54.2 (-56.1 to -52.2)	-46.6 (-48.6 to -44.7)	-59.1 (-61.0 to -57.1)	-50.8 (-52.8 to -48.9)

Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg: Mean Difference (Final Values): -14.7 (95% CI -17.5 to -12.0), p <0.001, ANCOVA
Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg: Mean Difference (Final Values): -7.5 (95% CI -10.3 to -4.8), p <0.001, ANCOVA
Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg: Mean Difference (Final Values): -8.2 (95% CI -11.0 to -5.5), p <0.001, ANCOVA

Population analysed: Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

5 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
Atorvastatin 10 mg	4 of 257 (1.6%)	26 of 257 (10.1%)	Not reported
Ezetimibe 10 mg/Simvastatin 20 mg	8 of 256 (3.1%)	32 of 256 (12.5%)	Not reported
Atorvastatin 20 mg	3 of 258 (1.2%)	26 of 258 (10.1%)	Not reported
Ezetimibe 10 mg/Simvastatin 40 mg	3 of 257 (1.2%)	32 of 257 (12.5%)	Not reported
Atorvastatin 40 mg	5 of 256 (2%)	30 of 256 (11.7%)	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.
Results publication: PubMed 21029821Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Not yet recruitingPhase 4
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Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingObservational study
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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 Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg and Atorvastatin 20 mg in people with Hypercholesterolemia, 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 2 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 25 May 2010). 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 12 (time frame: Baseline and 12 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 NCT00535405, which also lists 1 linked publication.

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.