HypercholesterolemiaPhase 4NCT00652327
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)
A Phase 4 study testing Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) and Double Statin (simvastatin, atorvastatin, or pravastatin) in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) and Double Statin (simvastatin, atorvastatin, or pravastatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2007
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 80-120 patients will be recruited in this study. All patients must meet the following criteria and follow an NCEP or similar cholesterol-lowering dietary regimen throughout the study:
- Men or women ≧18 and ≦80 years of age (Female patients receiving hormone therapy [including hormone replacement therapy, and estrogen antagonist/agonist, or oral contraceptives] and maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 must be willing to continue the same regimen throughout the study. Females of childbearing potential must be using a medically acceptable method of birth control).
- Willing to follow an NCEP Therapeutic Lifestyle Changes (TLC) or similar cholesterol-lowering diet for the duration of the study.
- Patients with hypercholesterolemia who cannot achieve the optimal therapeutic goal with previous statin treatment (simvastatin 20 mg, atorvastatin 10 mg or pravastatin 20 mg alone for at least 12 weeks) will be enrolled into study. The treatment goal in primary prevention is LDL-C <160 mg/dL or LDL-C <130 mg/dL patient with ≧ 2 risk factors (risk factors: hypertension, male ≧ 45 years old, family of premature coronary artery disease [CAD], female ≧ 55 years old or menopause without hormone replace therapy, smoking); LDL-C ≤ 100 mg/dL in CAD patients (documented by coronary angiogram, positive treadmill test or thallium scan), or diabetes mellitus (DM) patients (Ante Cibum [AC][fasting plasma glucose] >126 mg/dL, Post Cibum [PC] [oral glucose tolerance test] > 200 mg/dL, World Health Organization criteria), ischemic stroke (neurological dysfunction with documented diagnosis with computed tomography [CT] or magnetic resonance imaging [MRI]), peripheral artery disease.
- Triglyceride (TG) concentrations ≦ 400 mg/dL.
- Liver transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≦ 2 x upper limit of normal (ULN) with no active liver disease and creatine kinase (CK) ≦ 2 x ULN at screen visit.
Who cannot join
- The following conditions preclude patients from entry into this study:
- Women who are pregnant or lactating.
- History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy
- Patients who have been treated with any other investigational drug within 3 months of visit 1.
- Patients previously randomized to a study with ezetimibe.
- Active liver disease or Impaired liver function tests (ALT, AST > 2xULN).
Show all 22Show fewer
- Impaired renal function ( serum creatinine ≧1.5 mg/dL) or nephrotic syndrome at visit 1
- Unstable angina
- Acute myocardial infarction, coronary bypass surgery within the previous six months of visit 1.
- Uncontrolled cardiac arrhythmias
- Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mmHg or diastolic > 100 mmHg at visit 1.
- Poorly controlled diabetes mellitus patient (Patients who are under insulin injection and HbA1c>10.0%). If the patient is treated with medication for diabetes, the medication will be unchanged during the study period.
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoprotein, e.g. hypothyroidism (thyroid-stimulating hormone [TSH] > 5.5 uIU/mL). However, patients who are on a stable therapy of thyroid replacement therapy for at least 6 weeks are eligible for enrollment.
- Patients hypersensitive to HMG-CoA reductase inhibitors or ezetimibe.
- Patient who is unable to give informed consent (the patient with a legal representative to sign the informed consent is eligible to participate the study).
- Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or confound the results of the study.
- Prohibited concomitant therapies.
- Medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil and human immunodeficiency virus (HIV) protease inhibitors.
- Lipid-lowering agents including fish oils, Cholestin, bile-acid sequestrants, and niacin (<200 mg/day) taken within 6 weeks and fibrates taken within 8 weeks prior to enrollment.
- Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and treated with a stable regimen for at least 6 weeks prior to enrollment.
- Treatment with psylium, other fiber-based laxatives, and/or over-the-counter (OTC) therapies known to affect serum lipid levels, phytosterol margarines, unless treated with a stable regimen for at least 6 weeks prior to enrollment, and patient agrees to remain on constant regimen for the duration of the study.
- Patient is consuming > 250 ml of grapefruit juice per day.
About this study
Official title: A Multicenter, Randomized, Open-labeled, Parallel Group Comparison Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Ongoing Statin in the Treatment of Hypercholesterolemia.
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin), Double Statin (simvastatin, atorvastatin, or pravastatin)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin)Drug
ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks
Double Statin (simvastatin, atorvastatin, or pravastatin)Drug
simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe + Statin | Experimental | Not described Receives: Drug: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) |
| Double Statin | Active comparator | Not described Receives: Drug: Double Statin (simvastatin, atorvastatin, or pravastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment
Measured: Assessed at the end of 8 weeks of treatment (from baseline to endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startDec 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 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
- NCT00652327
- Sponsor's protocol ID
- P04355
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yu CC, Lai WT, Shih KC, Lin TH, Lu CH, Lai HJ, Hanson ME, Hwang JJ. Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial. BMC Res Notes. 2012 May 23;5:251. doi: 10.1186/1756-0500-5-251.
PubMed 22621316
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-labeled, Parallel Group Comparison Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Ongoing Statin in the Treatment of Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT00652327
- Acronym / sponsor ID
- P04355
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 10 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe + Statin | Experimental | Drug: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) |
| Double Statin | Active comparator | Drug: Double Statin (simvastatin, atorvastatin, or pravastatin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 80-120 patients will be recruited in this study. All patients must meet the following criteria and follow an NCEP or similar cholesterol-lowering dietary regimen throughout the study:
- Men or women ≧18 and ≦80 years of age (Female patients receiving hormone therapy [including hormone replacement therapy, and estrogen antagonist/agonist, or oral contraceptives] and maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 must be willing to continue the same regimen throughout the study. Females of childbearing potential must be using a medically acceptable method of birth control).
- Willing to follow an NCEP Therapeutic Lifestyle Changes (TLC) or similar cholesterol-lowering diet for the duration of the study.
- Patients with hypercholesterolemia who cannot achieve the optimal therapeutic goal with previous statin treatment (simvastatin 20 mg, atorvastatin 10 mg or pravastatin 20 mg alone for at least 12 weeks) will be enrolled into study. The treatment goal in primary prevention is LDL-C <160 mg/dL or LDL-C <130 mg/dL patient with ≧ 2 risk factors (risk factors: hypertension, male ≧ 45 years old, family of premature coronary artery disease [CAD], female ≧ 55 years old or menopause without hormone replace therapy, smoking); LDL-C ≤ 100 mg/dL in CAD patients (documented by coronary angiogram, positive treadmill test or thallium scan), or diabetes mellitus (DM) patients (Ante Cibum [AC][fasting plasma glucose] >126 mg/dL, Post Cibum [PC] [oral glucose tolerance test] > 200 mg/dL, World Health Organization criteria), ischemic stroke (neurological dysfunction with documented diagnosis with computed tomography [CT] or magnetic resonance imaging [MRI]), peripheral artery disease.
- Triglyceride (TG) concentrations ≦ 400 mg/dL.
Key exclusion criteria (22 listed)
- Women who are pregnant or lactating.
- History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy
- Patients who have been treated with any other investigational drug within 3 months of visit 1.
- Patients previously randomized to a study with ezetimibe.
- Active liver disease or Impaired liver function tests (ALT, AST > 2xULN).
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 + Statin (simvastatin, atorvastatin, or pravastatin)ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks | Drug | Ezetimibe + Statin |
| Double Statin (simvastatin, atorvastatin, or pravastatin)simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks | Drug | Double Statin |
Primary outcome
Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment
Time frame: Assessed at the end of 8 weeks of treatment (from baseline to endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22621316Yu CC, Lai WT, Shih KC, Lin TH, Lu CH, Lai HJ, Hanson ME, Hwang JJ. Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial. BMC Res Notes. 2012 May 23;5:251. doi: 10.1186/1756-0500-5-251.
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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 + Statin (simvastatin, atorvastatin, or pravastatin) and Double Statin (simvastatin, atorvastatin, or pravastatin) 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 6 inclusion and 22 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 9 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 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?
Yes. Results are posted in the registry (first posted 10 Jun 2010). 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?
Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment (time frame: Assessed at the end of 8 weeks of treatment (from baseline to endpoint)). 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 NCT00652327, 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 9 Feb 2022.