AtherosclerosisPhase 4NCT00166530
EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)
A Phase 4 study testing ezetimibe (+) simvastatin, simvastatin and atorvastatin in people with Atherosclerosis, run by Organon and Co.
Trial summary
In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- ezetimibe (+) simvastatin, simvastatin and atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female 18 years of age.
- Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
- lipid values while on statin monotherapy treatment: LDL-C level of > 2.5 mmol/L to * 5.0 mmol/L, triglycerides < 4.0 mmol/L and total cholesterol < 7.0 mmol/L.
- Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.
Who cannot join
- Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
- Patients who have been treated with any other investigational drug within 3 months of Visit 1.
- Patients who are pregnant or lactating.
- Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
About this study
Official title: A Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe (+) Simvastatin for Cholesterol Lowering, Compared the Dose of the Statin Used.
In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.
Read the detailed description
Patients with simvastatin 20 mg or atorvastatin 10 mg were randomized to (1) double statin dose (to 40 mg simvastatin or 20 mg atorvastatin) or (2) switch to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks.
- Conditions
- Atherosclerosis
- Being tested
- ezetimibe (+) simvastatin, simvastatin, atorvastatin
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibe (+) simvastatinDrug
Also called MK0653A, Vytorin®, INEGY™
Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
simvastatinDrug
Also called MK0733, Zocor®
Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
atorvastatinDrug
20 mg atorvastatin once daily for 12 weeks. Tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm 1: Active comparator Receives: Drug: simvastatin; Drug: atorvastatin |
| 2 | Experimental | Arm 2: Drug Receives: Drug: ezetimibe (+) simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment.
Measured: after 12 weeks of treatment
Secondary outcomes (1)
Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg will lower LDL-C more than doubling the statin dose as demonstrated by the percentage change from treated baseline in total and LDL-cholesterol after 12 weeks of treatment.
Measured: after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2007
- Study completionFeb 2007
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
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166530
- Sponsor's protocol ID
- 0653A-089
- Other IDs
- MK0653A-089, 2005_059
- Status last verified
- Feb 2022
- First submitted
- 9 Sep 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Roeters van Lennep HW, Liem AH, Dunselman PH, Dallinga-Thie GM, Zwinderman AH, Jukema JW. The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr Med Res Opin. 2008 Mar;24(3):685-94. doi: 10.1185/030079908X273273. Epub 2008 Jan 25.
PubMed 18226326
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 Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe (+) Simvastatin for Cholesterol Lowering, Compared the Dose of the Statin Used.
- ClinicalTrials.gov ID
- NCT00166530
- Acronym / sponsor ID
- 0653A-089
- Conditions
- Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 14 Sep 2005 (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.
In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.
Detailed description
Patients with simvastatin 20 mg or atorvastatin 10 mg were randomized to (1) double statin dose (to 40 mg simvastatin or 20 mg atorvastatin) or (2) switch to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: simvastatin, Drug: atorvastatinArm 1: Active comparator |
| 2 | Experimental | Drug: ezetimibe (+) simvastatinArm 2: Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is male or female 18 years of age.
- Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
- lipid values while on statin monotherapy treatment: LDL-C level of > 2.5 mmol/L to * 5.0 mmol/L, triglycerides < 4.0 mmol/L and total cholesterol < 7.0 mmol/L.
- Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.
Key exclusion criteria (4 listed)
- Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
- Patients who have been treated with any other investigational drug within 3 months of Visit 1.
- Patients who are pregnant or lactating.
- Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
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 (+) simvastatinAlso: MK0653A, Vytorin®, INEGY™Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets | Drug | 2 |
| simvastatinAlso: MK0733, Zocor®Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets | Drug | 1 |
| atorvastatin20 mg atorvastatin once daily for 12 weeks. Tablets | Drug | 1 |
Primary outcome
Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment.
Time frame: after 12 weeks of treatment
1 secondary outcome
Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg will lower LDL-C more than doubling the statin dose as demonstrated by the percentage change from treated baseline in total and LDL-cholesterol after 12 weeks of treatment.
Time frame: after 12 weeks of treatment
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.
- Derived from this study: PubMed 18226326Roeters van Lennep HW, Liem AH, Dunselman PH, Dallinga-Thie GM, Zwinderman AH, Jukema JW. The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr Med Res Opin. 2008 Mar;24(3):685-94. doi: 10.1185/030079908X273273. Epub 2008 Jan 25.
- Click here to access a synopsis of the study results.Link provided by the sponsor.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezetimibe (+) simvastatin, simvastatin and atorvastatin in people with 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 4 inclusion and 4 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. 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?
Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment. (time frame: after 12 weeks of treatment). 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 NCT00166530, 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.