HypercholesterolemiaPhase 4NCT00794677
Effects of Ezetimibe on the Absorption of Oxidized Cholesterol
A Phase 4 study testing ezetimibe in people with Hypercholesterolemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- 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
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently pregnant or lactating and is highly unlikely to conceive
- Body Mass Index (BMI) between 20-30 kilograms per meter squared (kg/m2) inclusive.
- Body weight, as reported by patient, stable (±2 kg) for >6 weeks
- Plasma low density lipoprotein cholesterol (LDL-C) between 130 and 180 milligrams per deciliter (mg/dL) inclusive. Note: One retest allowed.
- Triglyceride (TG) concentrations ≤150 mg/dL. Note: One retest allowed.
- Fasting blood glucose <110 mg/dL and hemoglobin A1c (HbA1C) ≤ 6 percent at Visit 1. Note: One retest allowed.
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- Liver transaminases (ALT, AST) ≤1.5 x upper limit of normal (ULN) and no active liver disease. Note: One retest allowed.
- Creatine Phosphokinase (CPK) ≤2x ULN. Note: One retest allowed.
- Willingness to maintain a stable diet for the duration of the study.
- Can understand and comply with study procedures and signs a written informed consent.
- Patient is ≥80 precent compliant with dosing during Placebo Run-In Period or, in the opinion of the investigator, is able to maintain ≥80 percent therapy compliance during the active treatment period of the study.
Who cannot join
- Lipid-lowering therapy and replacement of this therapy with study medication is considered inappropriate by the investigator.
- Consumes an average of more than 2 alcoholic drinks per day.
- Smokes.
- Currently engages in a vigorous exercise regimen or intensive exercise bouts >4x per month.
- Treated with any other investigational drug within 30 days of Visit 1.
- Hypersensitivity or intolerance to ezetimibe or any component of this medication.
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- Any condition or situation which poses a risk to the patient or interfere with participation in the study.
- Congestive heart failure.
- Uncontrolled cardiac arrhythmias.
- History of myocardial infarction, stroke, or any other clinical manifestation of coronary, cerebral, or peripheral vascular disease.
- Uncontrolled hypertension
- Impaired renal function, nephrotic syndrome or other clinically significant renal disease at Visit 1.
- Active or chronic hepatobiliary or hepatic disease.
- History of irritable bowel syndrome, ileal bypass, gastric bypass or any gastrointestinal disorder/condition associated with malabsorption.
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins.
- Type I or Type II diabetes mellitus.
- Disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- Human Immunodeficiency Virus (HIV) positive.
- History of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
- History of uncontrolled psychiatric illness or drug/alcohol abuse within the past 5 years. Individuals with psychiatric illness adequately controlled and stable on pharmacotherapy may be enrolled at the discretion of the investigator.
- Lipid-lowering agents taken within 6 weeks and fibrates taken within 8 weeks prior to visit 3.
- Cardiovascular medications are acceptable provided the patient has been on a stable regimen for at least 6 weeks prior to Visit 3 and indicates a willingness to continue the stable regimen for the duration of the study.
- Supplementation with antioxidants beyond a standard multivitamin for the duration of the study.
- Psyllium, other fiber-based laxatives, and/or over the counter (OTC) therapies known to affect serum lipid levels taken within 6 weeks of Visit 3.
- Female patients receiving hormone replacement therapy, any estrogen antagonist/agonist or hormonal contraceptives.
- Treatment with cyclosporine except for ophthalmic indication
- Anti-obesity medications such as orlistat or sibutramine taken within 3 months prior to Visit 1.
- Therapeutic doses of systemic corticosteroids except inhaled steroid therapy (for example, Pulmicort®) maintained on a stable dosing regimen for at least 6 weeks prior to randomization (Visit 3) and throughout the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center
Berkeley, California, 94705
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Plasma Appearance of 7-Ketocholesterol After an Oral Bolus in Patients With Primary Hypercholesterolemia
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol.
Read the detailed description
There are a number of cholesterol-lowering drugs available that can lower blood cholesterol to a healthier level. Zetia™ (ezetimibe) 10 mg is available by prescription for the treatment of high cholesterol. While Zetia has been shown to inhibit the absorption of dietary cholesterol into the bloodstream, its effects on oxysterol absorption from the diet have not been completely evaluated.
- Conditions
- Hypercholesterolemia
- Being tested
- ezetimibe, placebo
- Keywords
- Hypercholesterolemia, Oxysterol, Ezetimibe, Zetia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibeDrug
Also called Zetia
Blinded study medication (ezetimibe 10 mg in tablet form) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
placeboDrug
Also called Sugar Pill
Blinded study medication (matched placebo) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo medication will be taken orally once daily in the morning on rising either during the first intervention period or the second intervention period. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. Receives: Drug: placebo |
| ezetimibe | Experimental | 10 mg medication will be taken orally once daily in the morning on rising either during the first intervention period or the second intervention period. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. Receives: Drug: ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus
Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo
Measured: 6 weeks
Secondary outcomes (1)
Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus
Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.
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 posted20 Nov 2008 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionSep 2008
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, M.D., Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794677
- Sponsor's protocol ID
- MM6997
- Status last verified
- Feb 2021
- First submitted
- 19 Nov 2008
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Plasma Appearance of 7-Ketocholesterol After an Oral Bolus in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00794677
- Acronym / sponsor ID
- MM6997
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Oxysterol, Ezetimibe, Zetia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Merck Schering-Plough
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 4 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol.
Detailed description
There are a number of cholesterol-lowering drugs available that can lower blood cholesterol to a healthier level. Zetia™ (ezetimibe) 10 mg is available by prescription for the treatment of high cholesterol. While Zetia has been shown to inhibit the absorption of dietary cholesterol into the bloodstream, its effects on oxysterol absorption from the diet have not been completely evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: placeboPlacebo medication will be taken orally once daily in the morning on rising either during the first intervention period or the second intervention period. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. |
| ezetimibe | Experimental | Drug: ezetimibe10 mg medication will be taken orally once daily in the morning on rising either during the first intervention period or the second intervention period. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Not currently pregnant or lactating and is highly unlikely to conceive
- Body Mass Index (BMI) between 20-30 kilograms per meter squared (kg/m2) inclusive.
- Body weight, as reported by patient, stable (±2 kg) for >6 weeks
- Plasma low density lipoprotein cholesterol (LDL-C) between 130 and 180 milligrams per deciliter (mg/dL) inclusive. Note: One retest allowed.
- Triglyceride (TG) concentrations ≤150 mg/dL. Note: One retest allowed.
Key exclusion criteria (28 listed)
- Lipid-lowering therapy and replacement of this therapy with study medication is considered inappropriate by the investigator.
- Consumes an average of more than 2 alcoholic drinks per day.
- Smokes.
- Currently engages in a vigorous exercise regimen or intensive exercise bouts >4x per month.
- Treated with any other investigational drug within 30 days of Visit 1.
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: ZetiaBlinded study medication (ezetimibe 10 mg in tablet form) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. | Drug | ezetimibe |
| placeboAlso: Sugar PillBlinded study medication (matched placebo) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period. | Drug | Sugar Pill |
Primary outcome
Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus
Time frame: 6 weeks
Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo
1 secondary outcome
Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald M Krauss, M.D. principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezetimibe in people with Hypercholesterolemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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 11 inclusion and 28 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 Mar 2021. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2009). 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?
Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus (time frame: 6 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 9 Mar 2021.