HypercholesterolemiaPhase 3NCT00651404
Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)
A Phase 3 study testing Ezetimibe in people with Hypercholesterolemia and Atherosclerosis, run by Organon and Co.
Trial summary
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Atherosclerosis
- What is being tested?
- Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years and <= 75 years of age with LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit
- documented coronary heart disease
- currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3
- liver transaminases (ALT, AST) < 50 % above the upper limit of normal, with no active liver disease, and CK < 50 % above the upper limit of normal at Baseline Visit.
- cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history.
- women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and continue same regimen during the study.
- women of non-childbearing potential or using acceptable method of birth control.
- subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.
Who cannot join
- Subjects whose body mass index is >=30 kg/sqm at baseline.
- Subjects who consume >14 alcoholic drinks per week.
- Any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
- Women who are pregnant or nursing.
- Subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.
About this study
Official title: A Multicenter, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease.
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Being tested
- Ezetimibe, Placebo
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called SCH 058235, Zetia
oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
PlaceboDrug
oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Experimental | Not described Receives: Drug: Ezetimibe |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to end of treatment in LDL-C.
Measured: 6 weeks
Secondary outcomes (3)
Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines.
Measured: 6 weeks
Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides.
Measured: 6 weeks
Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651404
- Sponsor's protocol ID
- P03406
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease.
- ClinicalTrials.gov ID
- NCT00651404
- Acronym / sponsor ID
- P03406
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Experimental | Drug: Ezetimibe |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >=18 years and <= 75 years of age with LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit
- documented coronary heart disease
- currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3
- liver transaminases (ALT, AST) < 50 % above the upper limit of normal, with no active liver disease, and CK < 50 % above the upper limit of normal at Baseline Visit.
- cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history.
Key exclusion criteria (5 listed)
- Subjects whose body mass index is >=30 kg/sqm at baseline.
- Subjects who consume >14 alcoholic drinks per week.
- Any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
- Women who are pregnant or nursing.
- Subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.
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 |
|---|---|---|
| EzetimibeAlso: SCH 058235, Zetiaoral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily) | Drug | Ezetimibe |
| Placebooral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily) | Drug | Placebo |
Primary outcome
Percent change from baseline to end of treatment in LDL-C.
Time frame: 6 weeks
3 secondary outcomes
Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines.
Time frame: 6 weeks
Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides.
Time frame: 6 weeks
Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ezetimibe in people with Hypercholesterolemia and Atherosclerosis, 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 8 inclusion and 5 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 17 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 end of treatment in LDL-C. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.