AtherosclerosisPhase 4NCT00651274
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
A Phase 4 study testing Ezetimibe in people with Atherosclerosis and Hypercholesterolemia, run by Organon and Co.
Trial summary
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis, Hypercholesterolemia, Coronary Heart Disease
- 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
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2003to 1 Aug 2004
- Phase
- Phase 4
- 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
- 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 >= 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).
- Subjects must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).
- 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.
- Subject must be currently taking simvastatin 20 mg daily and by history has taken 80% of daily evening doses for the preceding 6 weeks prior to Visit 3 (Baseline Visit).
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- 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 maintained a cholesterol lowering diet program for at least 4 weeks prior to the study and be willing to continue the same diet program during the study.
- 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 become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., 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 remain on their cholesterol-lowering diet and their exercise regimen for the duration of the study.
Who cannot join
- Subjects whose body mass index (BMI) is >= 30 Kg/m^2 at Visit 3 (Baseline Visit).
- Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
- Any condition or situation which, 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 the designated washout periods for any of the prohibited medications
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 Simvastatin 20 Mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
- Being tested
- Ezetimibe, Placebo
- Medical subject headings
- Atherosclerosis, Hypercholesterolemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called SCH 58235
oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
PlaceboDrug
oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
| 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 in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone.
Measured: 6 weeks
Secondary outcomes (2)
Percentage of subjects who achieve target LDL-C as defined by the ESC or NCEP guidelines with ezetimibe added to simvastatin versus continued simvastatin alone
Measured: 6 weeks
Percent change from baseline in total cholesterol, HDL-C and triglycerides with ezetimibe added to simvastatin versus continued simvastatin alone.
Measured: 6 weeks
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 start1 Apr 2003
- Primary completion1 Aug 2004
- Study completion1 Aug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 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
- NCT00651274
- Sponsor's protocol ID
- P03476
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
PubMed 18545068
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. 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 Simvastatin 20 Mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00651274
- Acronym / sponsor ID
- P03476
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Apr 2003 (actual)
- Primary completion
- 1 Aug 2004 (actual)
- Study completion
- 1 Aug 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.
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
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 (14 listed)
- 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 >= 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).
- Subjects must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).
- 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.
Key exclusion criteria (5 listed)
- Subjects whose body mass index (BMI) is >= 30 Kg/m^2 at Visit 3 (Baseline Visit).
- Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
- Any condition or situation which, 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 the designated washout periods for any of the prohibited medications
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 58235oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin) | Drug | Ezetimibe |
| Placebooral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin) | Drug | Placebo |
Primary outcome
Percent change from baseline in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone.
Time frame: 6 weeks
2 secondary outcomes
Percentage of subjects who achieve target LDL-C as defined by the ESC or NCEP guidelines with ezetimibe added to simvastatin versus continued simvastatin alone
Time frame: 6 weeks
Percent change from baseline in total cholesterol, HDL-C and triglycerides with ezetimibe added to simvastatin versus continued simvastatin alone.
Time frame: 6 weeks
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 15 Aug 2024.
- Results publication: PubMed 18545068Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
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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 4 study testing Ezetimibe in people with Atherosclerosis and 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 14 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 15 Aug 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. 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 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?
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 in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone. (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 NCT00651274, 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 15 Aug 2024.