DyslipidemiaNCT00299884
Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy
An observational study of Dyslipidemia and Vascular Disease, run by Queen's University at 1 site in Canada.
Trial summary
The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dyslipidemia, Vascular Disease
- What is being tested?
- Lipitor 20 mg and Combination Ezetrol 10 mg and Lipidil Supra 160 mg
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Jul 2006
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 18-85 with elevated LDL-C levels 3.0 mmol/L and greater.
Who may be able to join
- -Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.
Who cannot join
- Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);
- Creatine kinase levels more than two times the upper limit of normal;
- Uncontrolled ethanol use (this may affect compliance);
- Pregnant or breastfeeding women or women not using adequate contraceptive methods;
- Previous history of intolerance or adverse effects with statins;
- Previous history of intolerance or adverse effects with fibric acid derivatives;
Show all 10Show fewer
- Previous history of intolerance or adverse effects with ezetimibe;
- Uncontrolled diabetes (HbA1c > 10%);
- Recent myocardial infarction (within 6 weeks);
- Concurrent enrollment in another study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
Official title: The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol
The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.
Read the detailed description
It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.
Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.
- Conditions
- Dyslipidemia, Vascular Disease
- Being tested
- Lipitor 20 mg, Combination Ezetrol 10 mg and Lipidil Supra 160 mg
- Keywords
- Randomized, non-blinded, prospective, open-label, LDL-C, HDL-C
- Medical subject headings
- Dyslipidemias, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipitor 20 mgDrug
A/A for 6 weeks
Combination Ezetrol 10 mg and Lipidil Supra 160 mgDrug
a/a for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Lipitor 20 mg Receives: Drug: Lipitor 20 mg | |
| 2 | Lipidil Supra 160 mg and Ezetrol 10 mg Receives: Drug: Combination Ezetrol 10 mg and Lipidil Supra 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C.
Measured: 12 weeks
Secondary outcomes (1)
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering triglyceride levels, raising HDL-C levels and lowering of hsCRP levels.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startJan 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephen LaHaye, Queen's University
- Investigators
- Stephen A LaHaye, MD, Principal investigator, Vascular Disease Prevention and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299884
- Sponsor's protocol ID
- DMED-816-04
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2005
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol
- ClinicalTrials.gov ID
- NCT00299884
- Acronym / sponsor ID
- DMED-816-04
- Conditions
- Dyslipidemia, Vascular Disease
- Keywords
- Randomized, non-blinded, prospective, open-label, LDL-C, HDL-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 7 Mar 2006 (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 aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.
Detailed description
It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.
Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Lipitor 20 mgLipitor 20 mg |
| 2 | – | Drug: Combination Ezetrol 10 mg and Lipidil Supra 160 mgLipidil Supra 160 mg and Ezetrol 10 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 18-85 with elevated LDL-C levels 3.0 mmol/L and greater.
Key inclusion criteria (1 listed)
- -Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.
Key exclusion criteria (10 listed)
- Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);
- Creatine kinase levels more than two times the upper limit of normal;
- Uncontrolled ethanol use (this may affect compliance);
- Pregnant or breastfeeding women or women not using adequate contraceptive methods;
- Previous history of intolerance or adverse effects with statins;
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 |
|---|---|---|
| Lipitor 20 mgA/A for 6 weeks | Drug | 1 |
| Combination Ezetrol 10 mg and Lipidil Supra 160 mga/a for 6 weeks | Drug | 2 |
Primary outcome
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C.
Time frame: 12 weeks
1 secondary outcome
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering triglyceride levels, raising HDL-C levels and lowering of hsCRP levels.
Time frame: 12 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 29 Mar 2016.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Stephen A LaHaye, MD principal investigator
Vascular Disease Prevention and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and Vascular Disease, run by Queen's University at 1 site in Canada.
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 1 inclusion and 10 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 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C. (time frame: 12 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 29 Mar 2016.