HypercholesterolemiaPhase 3NCT00276458

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

A Phase 3 study testing Comparator: atorvastatin and Comparator: ezetimibe 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

Search all trials

Trial summary

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Comparator: atorvastatin and Comparator: ezetimibe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: No sites listed yet
Study dates: Feb 2006to Jan 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

Patient with LDL-C >100 mg/dL \& on a stable dose of atorvastatin 20 mg

Who cannot join

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Patient with diabetes or coronary heart disease

About this study

Official title: A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

Conditions: Hypercholesterolemia
Being tested: Comparator: atorvastatin, Comparator: Placebo, Comparator: ezetimibe, Comparator: Placebo.
Medical subject headings: Hypercholesterolemia

What participants receive

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

Comparator: atorvastatinDrug
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Comparator: PlaceboDrug
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Comparator: ezetimibeDrug
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Comparator: Placebo.Drug
Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Study groups in NCT00276458
Study group	Role	What they receive
1	Active comparator	Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). Receives: Drug: Comparator: atorvastatin; Drug: Comparator: Placebo
2	Experimental	Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). Receives: Drug: Comparator: ezetimibe; Drug: Comparator: Placebo.

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) at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 weeks

Secondary outcomes (11)

Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 weeks
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Total-Cholesterol at Week 6
([6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Triglycerides (TG) at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 weeks
Percent Change From Baseline in Apolipoprotein B at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
[(6 week value - baseline value)/baseline value]*100%.
Measured: 6 Weeks
Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
Measured: 6 weeks

Timeline

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

Feb 2006Jan 2008

First posted13 Jan 2006 (estimated)
Study startFeb 2006
Primary completionJan 2008
Study completionJan 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 (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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00276458
Sponsor's protocol ID: 0653-079
Other IDs: 2005_104
Status last verified: Feb 2022
First submitted: 10 Jan 2006
Last updated: 13 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.
PubMed 19026302

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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg
ClinicalTrials.gov ID: NCT00276458
Acronym / sponsor ID: 0653-079
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 13 Jan 2006 (estimated)
Results: Posted 8 Jul 2009

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: 2

Arm	Type	Receives
1	Active comparator	Drug: Comparator: atorvastatin, Drug: Comparator: PlaceboAtorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
2	Experimental	Drug: Comparator: ezetimibe, Drug: Comparator: Placebo.Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).

Who may qualify

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

Key inclusion criteria (1 listed)

Patient with LDL-C >100 mg/dL \& on a stable dose of atorvastatin 20 mg

Key exclusion criteria (3 listed)

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Patient with diabetes or coronary heart disease

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
Comparator: atorvastatinAtorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks	Drug	1
Comparator: PlaceboAtorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks	Drug	1
Comparator: ezetimibeAtorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.	Drug	2
Comparator: Placebo.Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.	Drug	2

Primary outcome

Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
Time frame: 6 weeks
[(6 week value - baseline value)/baseline value]*100%.

11 secondary outcomes

Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
Time frame: 6 weeks
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Total-Cholesterol at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Triglycerides (TG) at Week 6
Time frame: 6 weeks
Percent Change From Baseline in Apolipoprotein B at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: 6 Weeks
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
Time frame: 6 Weeks
Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
Time frame: 6 weeks

Results and safety

Results posted to the registry on 8 Jul 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
Atorvastatin + Ezetimibe	98	92
Atorvastatin	98	91

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

Time frame: 6 weeks. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Atorvastatin + Ezetimibe n = 92	Atorvastatin n = 92
Value	-30.8 (-34.5 to -27.0)	-10.9 (-14.7 to -7.1)

Atorvastatin + Ezetimibe vs Atorvastatin: Mean Difference (Final Values): -19.9 (95% CI -25.2 to -14.5), p <0.001, ANCOVA

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.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin + Ezetimibe	0 of 96 (0%)	17 of 96 (17.7%)	Not reported
Atorvastatin	0 of 98 (0%)	22 of 98 (22.4%)	Not reported

Limitations and caveats (from the sponsor): 194 out of 196 randomized patients took at least one dose of blinded study therapy and were included in the safety analysis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19026302Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.
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 Comparator: atorvastatin and Comparator: ezetimibe 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 1 inclusion and 3 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 13 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 8 Jul 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-Cholesterol (LDL-C) at Week 6 (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 NCT00276458, 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 13 May 2024.