HypercholesterolemiaPhase 4NCT00166504

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

A Phase 4 study testing ezetimibe (+) simvastatin and atorvastatin 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: ezetimibe (+) simvastatin and atorvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: No sites listed yet
Study dates: Oct 2005to Oct 2007
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of hypercholesterolemia
LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Who cannot join

Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

About this study

Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Conditions: Hypercholesterolemia
Being tested: ezetimibe (+) simvastatin, atorvastatin
Medical subject headings: Hypercholesterolemia

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®
simvastatin/ezetimibe 10/20 mg
atorvastatinDrug
Also called Lipitor®
atorvastatin 10 mg

Study groups in NCT00166504
Study group	Role	What they receive
Vytorin	Experimental	Ezetimibe 10 mg/Simvastatin 20 mg Receives: Drug: ezetimibe (+) simvastatin
Atorvastatin	Active comparator	Atorvastatin 10 mg Receives: Drug: atorvastatin

What is being measured

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

LDL-C Lowering Efficacy
LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
Measured: 6 weeks

Timeline

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

Oct 2005Oct 2007

First posted14 Sep 2005 (estimated)
Study startOct 2005
Primary completionOct 2007
Study completionOct 2007

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00166504
Sponsor's protocol ID: 0653A-092
Other IDs: MK0653A-092, 2005_070
Status last verified: Feb 2022
First submitted: 9 Sep 2005
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT00166504
Acronym / sponsor ID: 0653A-092
Conditions: Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 14 Sep 2005 (estimated)
Results: Posted 5 Nov 2008

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: None (open label)
Number of arms: 2

Arm	Type	Receives
Vytorin	Experimental	Drug: ezetimibe (+) simvastatinEzetimibe 10 mg/Simvastatin 20 mg
Atorvastatin	Active comparator	Drug: atorvastatinAtorvastatin 10 mg

Who may qualify

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

Key inclusion criteria (3 listed)

Clinical diagnosis of hypercholesterolemia
LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Key exclusion criteria (1 listed)

Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

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®simvastatin/ezetimibe 10/20 mg	Drug	Vytorin
atorvastatinAlso: Lipitor®atorvastatin 10 mg	Drug	Atorvastatin

Primary outcome

LDL-C Lowering Efficacy
Time frame: 6 weeks
LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

Results and safety

Results posted to the registry on 5 Nov 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vytorin	108	103
Atorvastatin	95	91

Primary outcome: LDL-C Lowering Efficacy

Time frame: 6 weeks. Least squares mean (Standard Deviation). Unit: Percent Change from Baseline

Measure	Vytorin n = 105	Atorvastatin n = 93
Value	-51 (14.7)	-41 (16)

Vytorin vs Atorvastatin: Mean Difference (Net): -10 (95% CI -14.3 to -5.7), p <0.001, ANOVA

Population analysed: Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vytorin	0 of 108 (0%)	0 of 108 (0%)	Not reported
Atorvastatin	0 of 95 (0%)	0 of 95 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia

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 4 study testing ezetimibe (+) simvastatin and atorvastatin 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 1 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 22 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 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?

Yes. Results are posted in the registry (first posted 5 Nov 2008). 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?

LDL-C Lowering Efficacy (time frame: 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 NCT00166504.

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 22 May 2024.