HyperlipidemiaPhase 3NCT00195793
A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin
A Phase 3 study testing fenofibrate, ezetimibe and atorvastatin in people with Hyperlipidemia, run by Abbott.
Trial summary
The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- fenofibrate, ezetimibe and atorvastatin
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >= 18 years of age, any race, and any gender.
- Subjects must have the following fasting parameters:
- LDL-C > 100 mg/dL and < 190 mg/dL.
- TG level >= 175 mg/dL and < 1000 mg/dL.
- HDL-C < 40 mg/dL (men) and < 50 mg/dL (women).
- Subjects must have one or more of the following:
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- Treated or untreated hypertension defined as blood pressure (BP)
- 130 mmHg >= 85 mmHg (systolic / diastolic).
- Waist circumference > 88 cm (35 inches) for women or > 102 cm (40 inches) for men.
- Fasting glucose defined as >= 100 mg/dL but <= 125 mg/dL.
- Subject has, in the opinion of the investigator, a life expectancy greater than 6 months.
- Female subjects must have a negative pregnancy test prior to study enrollment.
- Female subjects of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study.
- Subject must be willing to observe the Step I Diet recommended by the NCEP throughout the study.
- Subject must be willing to participate in the study and to complete all follow-up assessments.
Who cannot join
- Subject has a known hypersensitivity to fenofibrate, ezetimibe, or atorvastatin
- Subject has been previously enrolled in this study.
- Subject has used an investigational drug within 30 days of study entry.
- Subject has been diagnosed with Type I or Type II Diabetes Mellitus or is currently being treated with anti-diabetic medication, or has a fasting glucose >= 126 mg/dL.
- Subject has a history of pancreatitis or cholelithiasis or a history of gastric or duodenal ulcer within 3 months of study entry.
- Subject has hematologic, digestive, or central nervous system disorder including cerebrovascular disease or degenerative disease that would limit study evaluation or participation.
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- Subject has had a myocardial infarction, coronary bypass surgery, or angioplasty within 6 months of study entry.
- Subject has unstable or severe peripheral artery disease within 3 months of study entry.
- Subject has unstable angina pectoris or uncontrolled cardiac arrhythmias.
- Subject has congestive heart failure (CHF) as defined by NYHA Class III or IV
- Subject has coagulopathy (PT or PTT > 1.25 times control).
- Subject has known impairment of renal function (serum creatinine > 1.5 mg/dL), dysproteinemia, nephrotic-range proteinuria, or other renal disease.
- Subject has active or chronic hepatobiliary or hepatic disease (subjects with AST or ALT > 2 times the upper limit of the central laboratory reference range).
- Subject is pregnant or lactating.
- Subject is receiving hormonal therapy.
- Subject has a known history of thyroid disease or other endocrine abnormality.
- Subject has a history of diagnosed hereditary or acquired myopathy.
- Subject is known to be HIV positive.
- Subject has a history of mental instability, drug or alcohol (as defined by greater than 14 drinks per week) abuse, or subject has been treated for severe psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study.
- Subject has received a solid organ transplant.
- Subject has a clinically significant, unstable, uncontrolled disease that could be adversely affected by study participation.
- Subject is unwilling or unable to consent to enter the study.
- Subject is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Prospective, Parallel Study to Compare the Safety and Efficacy of Fenofibrate or Ezetimibe as Add-On Therapy to Atorvastatin in Subjects With Combined Hyperlipidemia, Typical of the Metabolic Syndrome
The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.
- Conditions
- Hyperlipidemia
- Being tested
- fenofibrate, ezetimibe, atorvastatin
- Keywords
- Hyperlipidemia, fenofibrate, ezetimibe, atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrateDrug
ezetimibeDrug
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG.
Measured: Week 12
Secondary outcomes (1)
Advanced lipid and inflammatory parameters
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Double blind
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195793
- Sponsor's protocol ID
- M03-661
- Status last verified
- Oct 2007
- First submitted
- 14 Sep 2005
- Last updated
- 4 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Prospective, Parallel Study to Compare the Safety and Efficacy of Fenofibrate or Ezetimibe as Add-On Therapy to Atorvastatin in Subjects With Combined Hyperlipidemia, Typical of the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00195793
- Acronym / sponsor ID
- M03-661
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, fenofibrate, ezetimibe, atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- First posted
- 20 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.
The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is >= 18 years of age, any race, and any gender.
- Subjects must have the following fasting parameters:
- Subjects must have one or more of the following:
- Subject has, in the opinion of the investigator, a life expectancy greater than 6 months.
- Female subjects must have a negative pregnancy test prior to study enrollment.
Key exclusion criteria (23 listed)
- Subject has a known hypersensitivity to fenofibrate, ezetimibe, or atorvastatin
- Subject has been previously enrolled in this study.
- Subject has used an investigational drug within 30 days of study entry.
- Subject has been diagnosed with Type I or Type II Diabetes Mellitus or is currently being treated with anti-diabetic medication, or has a fasting glucose >= 126 mg/dL.
- Subject has a history of pancreatitis or cholelithiasis or a history of gastric or duodenal ulcer within 3 months of study entry.
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 |
|---|---|---|
| fenofibrate | Drug | – |
| ezetimibe | Drug | – |
| atorvastatin | Drug | – |
Primary outcome
Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG.
Time frame: Week 12
1 secondary outcome
Advanced lipid and inflammatory parameters
Time frame: Week 12
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 4 Oct 2007.
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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.
Global Medical Information study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fenofibrate, ezetimibe and atorvastatin in people with Hyperlipidemia, run by Abbott.
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 15 inclusion and 23 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 4 Oct 2007. 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?
Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG. (time frame: Week 12). 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 4 Oct 2007.