HypercholesterolemiaPhase 3NCT00650689
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)
A Phase 3 study testing Ezetimibe + Atorvastatin and Atorvastatin in people with Hypercholesterolemia and Atherosclerosis, run by Organon and Co.
Trial summary
The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Ezetimibe + Atorvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- May 2003to 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
- Diagnosis and Criteria for Inclusion:
- Diagnosis: This study was designed for untreated subjects with primary hypercholesterolemia with plasma LDL-C concentrations between >=3.3 mmol/L (130 mg/dL) to <=4.6 mmol/L (180 mg/dL) and triglyceride concentrations of <3.99 mmol/L (350 mg/dL), and coronary heart disease for whom diet and exercise have failed and now require drug therapy.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=18 years and <=75 years of age.
- Subjects must have an LDL-C concentration >=3.3 mmol/L (130 mg/dL) to <=4.6 mmol/L (180 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit).
- Subjects must have triglyceride concentrations of <3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).
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- Subjects must have documented coronary heart disease (CHD). For the purposes of this study, CHD will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of myocardial infarction; history of percutaneous coronary intervention (primarily PTCA with or without stent placement); symptomatic peripheral vascular disease (claudication); documented history of atherothrombotic cerebrovascular disease; and/or documented history of unstable angina or non-Q wave myocardial infarction.
- Subjects must not be currently taking an approved statin. Subjects with a previous history of statin use must have not used a statin for at least 6 months prior to Visit 3 (Baseline Visit).
- Subjects must have 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 Visit 3 (Baseline Visit).
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the investigator at Visit 3 (Baseline Visit).
- Subjects must have failed a cholesterol-lowering diet and exercise program of at least 4 weeks duration prior to Visit 3 (Baseline Visit).
- Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline visit).
- 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 be willing to continue the same regimen for the duration of the study.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who became sexually active) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
- Subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.
- Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to maintain their current cholesterol-lowering diet and their current exercise program for the duration of the study.
Who cannot join
- Subjects whose body mass index is >=30 kg/sqm at baseline.
- Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
- 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 Coadministration of Ezetimibe 10 mg With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease for Whom Diet and Exercise Have Failed.
The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. The primary variable is LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and triglycerides (TG). The following variables were used to assess the safety and compliance of the drug: vital signs and laboratory values. Variables were measured before the first administration of the drug and at the last administration of the drug, after 6 weeks of treatment. Adverse events were also assessed.
- Being tested
- Ezetimibe + Atorvastatin, Atorvastatin
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe + AtorvastatinDrug
Also called SCH 58235, Zetia, Lipitor
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
AtorvastatinDrug
Also called Lipitor
oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe + Atorvastatin | Experimental | Not described Receives: Drug: Ezetimibe + Atorvastatin |
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in LDL-C.
Measured: 6 weeks
Secondary outcomes (2)
Change from baseline to endpoint in total cholesterol, HDL-C, and triglycerides.
Measured: 6 weeks
Safety/tolerability: adverse events, laboratory test results, vital signs
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 startMay 2003
- 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
- 122 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
- NCT00650689
- Sponsor's protocol ID
- P03396
- 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 Coadministration of Ezetimibe 10 mg With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease for Whom Diet and Exercise Have Failed.
- ClinicalTrials.gov ID
- NCT00650689
- Acronym / sponsor ID
- P03396
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2003
- 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.
The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. The primary variable is LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and triglycerides (TG). The following variables were used to assess the safety and compliance of the drug: vital signs and laboratory values. Variables were measured before the first administration of the drug and at the last administration of the drug, after 6 weeks of treatment. Adverse events were also assessed.
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 + Atorvastatin | Experimental | Drug: Ezetimibe + Atorvastatin |
| Atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis: This study was designed for untreated subjects with primary hypercholesterolemia with plasma LDL-C concentrations between >=3.3 mmol/L (130 mg/dL) to <=4.6 mmol/L (180 mg/dL) and triglyceride concentrations of <3.99 mmol/L (350 mg/dL), and coronary heart disease for whom diet and exercise have failed and now require drug therapy.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=18 years and <=75 years of age.
- Subjects must have an LDL-C concentration >=3.3 mmol/L (130 mg/dL) to <=4.6 mmol/L (180 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit).
- Subjects must have triglyceride concentrations of <3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).
Key exclusion criteria (6 listed)
- Subjects whose body mass index is >=30 kg/sqm at baseline.
- Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
- 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.
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 + AtorvastatinAlso: SCH 58235, Zetia, Lipitororal tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks | Drug | Ezetimibe + Atorvastatin |
| AtorvastatinAlso: Lipitororal tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks | Drug | Atorvastatin |
Primary outcome
Change from baseline to endpoint in LDL-C.
Time frame: 6 weeks
2 secondary outcomes
Change from baseline to endpoint in total cholesterol, HDL-C, and triglycerides.
Time frame: 6 weeks
Safety/tolerability: adverse events, laboratory test results, vital signs
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 + Atorvastatin and Atorvastatin 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 16 inclusion and 6 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. 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?
Change from baseline to endpoint 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.