Phase 4
N=31
Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00701727 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Fecal Excretion of Plasma-derived Cholesterol — 1593; 1950 mg/day cholesterol excreted — p=0.019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ezetimibe (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Radiant Research
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fecal Excretion of Plasma-derived Cholesterol |
1593; 1950 | 0.019 sig |
| SECONDARY Change From Baseline in Total Cholesterol, From Fasting Plasma Samples |
219; 187 | <0.0001 sig |
| SECONDARY de Novo Cholesterol Synthesis (DNC) |
3.4; 4.7 | <0.001 sig |
| SECONDARY Cholesterol Efflux Rate (Ra Cholesterol) |
4.6; 4.4 | 0.12 |
| SECONDARY Triglycerides (TG) |
128; 121 | >0.05 |
| SECONDARY Low-density Lipoprotein (LDL); |
148; 116 | <0.0001 sig |
| SECONDARY High-density Lipoprotein (HDL) |
46; 45 | 0.95 |
Summary
This is a prospective, placebo-controlled, cross-over trial comparing the the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with secondary hypotheses that there will be a significant increase in de novo cholesterol synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and increase global RCT.
Eligibility Criteria
Inclusion Criteria
- male, non-smoker, 21-75 years of age
- female, non-smoker, 40-75 years of age
- post-menopausal women, as defined by lack of menses for at least 2 years and age >55, OR history of documented bilateral oophorectomy, confirmed with an elevated FSH at screening
- low-density lipoprotein (LDL) concentration between 130-200 mg/dL.
- triglyceride (TG) concentration 2*upper limit of normal, abnormal thyroid-stimulating hormone (TSH), fasting glucose >=126mg/dL
- renal impairment with creatinine clearance (CRCl)<80ml/min
- treatment within the last 2 months with drugs known to alter lipid metabolism including beta blockers, thiazide diuretics, bile acid resins, statins, ezetimibe, niacin, fibrates, plant stanol esters (eg Benecol,phyto sterols) and fishoils
- history of known coronary heart disease (CHD), stroke or prior revascularization procedure or peripheral vascular disease
- history of allergy to egg or soy products
- current or recent (past 12 months) of drug abuse or alcohol abuse. Alcohol use must be limited to no more than 2 drinks/day (1 drink=12 oz beer, 5 oz wine, or 1.5 oz hard liquor). Subject must be willing to avoid large day-to-day fluctuations in alcohol intake.
- participation in another clinical trial or exposure to any investigational agent within 30 days prior to Visit 1
- Individual has a condition the Principal Investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results, or put the subject at undue risk
Data sourced from ClinicalTrials.gov (NCT00701727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.