CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
ezetimibe +1 moredrug
Likely dose
ezetimibe 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00794677
NCT00794677Phase 4Completed
CompareCT.gov

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

UCSF Benioff Children's Hospital Oakland·interventional·Posted Nov 20, 2008·Updated Mar 9, 2021

In Brief

A Phase 4 clinical trial evaluating ezetimibe and placebo for Hypercholesterolemia. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
CollaboratorsMerck Schering-Plough

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2008
Enrollment StartJun 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.6 years ago

Interventions

ezetimibedrug

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

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.