AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT00276484

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

A Phase 3 study testing atorvastatin and 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

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 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?
atorvastatin and ezetimibe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
579 participants
Where
No sites listed yet
Study dates
Feb 2006to Mar 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 >70 mg/dL \& on a stable dose of atorvastatin 40 mg

Who cannot join

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin

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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Being tested
atorvastatin, ezetimibe
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • atorvastatinDrug

    Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks

  • atorvastatinDrug

    Atorvastatin 40 mg by mouth, once a day for 6 weeks

  • ezetimibeDrug

    Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.

Study groups in NCT00276484
Study groupRoleWhat they receive
1Active comparatorAtorvastatin 80 mg
Receives: Drug: atorvastatin
2ExperimentalAtorvastatin 40 mg + ezetimibe 10 mg
Receives: Drug: atorvastatin; Drug: ezetimibe

What is being measured

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

  1. Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C

    Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 weeks

Secondary outcomes (12)

  1. Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)

    Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 weeks

  2. Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  3. Percent Change From Baseline to Week 6 in Total-Cholesterol

    Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  4. Percent Change From Baseline to Week 6 in Triglycerides (TG)

    Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  5. Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)

    Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  6. Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)

    Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  7. Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio

    Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

    Measured: Baseline and 6 Weeks

  8. Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio

    Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

    Measured: Baseline and 6 Weeks

  9. Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio

    Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

    Measured: Baseline and 6 Weeks

  10. Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio

    Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

    Measured: Baseline and 6 Weeks

  11. Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)

    Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%

    Measured: Baseline and 6 Weeks

  12. Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 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.

  1. First posted13 Jan 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionFeb 2008
  4. Study completionMar 2008

Resources

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
579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276484
Sponsor's protocol ID
0653-090
Other IDs
2005_105
Status last verified
Feb 2022
First submitted
11 Jan 2006
Last updated
14 May 2024
Individual data sharing
No

Publications

  • Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23.

    PubMed 19026303

  • Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136. doi: 10.1186/1476-511X-9-136.

    PubMed 21118495

  • Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x.

    PubMed 20151997

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing atorvastatin and 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 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 14 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 13 Apr 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 to Week 6 in Low-Density Lipoprotein (LDL)-C (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 NCT00276484, which also lists 3 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 14 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in