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Sponsored by: |
Radiant Research |
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Information provided by: | Radiant Research |
ClinicalTrials.gov Identifier: | NCT00701727 |
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 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.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: ezetimibe Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ezetimibe (10mg/day)for 7 weeks
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Drug: ezetimibe
1 tablet,10mg, once a day, for 7 weeks
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2: Placebo Comparator
Placebo control
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Drug: Placebo
1 tablet, once a day, for 7 weeks
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The study will compare the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) on: 1) the efficiency of endogenous (plasma-derived) cholesterol excretion (%/day) 2) de novo cholesterol (DNC) synthesis ((%/day) 3) cholesterol efflux from tissues into blood (Ra), and 4) global RCT (efflux from tissues that is excreted as fecal sterols). Subjects will receive 7 weeks of either treatment or placebo, undergo RCT and DNC measurements, taking 10 days, then cross-over to the alternate placebo or treatment for an additional 7 weeks, followed by a second set of RCT and DNC measurements.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Kritschgau | 312-494-2233 | michaelKritschgau@radiantresearch.com |
Contact: Laura Dowling | 312-494-2339 | LauraDowling@radiantresearch.com |
United States, Illinois | |
Radiant Research | Recruiting |
Chicago, Illinois, United States, 60610 | |
Principal Investigator: Michael H Davidson, MD, FACC |
Principal Investigator: | Michael H Davidson, Md. FACC | Radiant Research |
Responsible Party: | Radiant Research ( Michael H. Davidson, MD, FACC ) |
Study ID Numbers: | Ezetimibe RCT-001 |
Study First Received: | June 17, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00701727 History of Changes |
Health Authority: | United States: Food and Drug Administration |
metabolic diseases metabolic disorder dyslipidemias lipid metabolism disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Antilipemic Agents Ezetimibe |
Anticholesteremic Agents Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Metabolic Diseases Hyperlipidemias Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Ezetimibe Anticholesteremic Agents Hypercholesterolemia Pharmacologic Actions Dyslipidemias Lipid Metabolism Disorders |