A Phase 3 interventional study of ezetimibe (plus simvastatin) and placebo (plus simvastatin) in Atherosclerosis, Hypercholesterolemia and Hyperlipoproteinemia Type II, sponsored by Organon and Co. Completed. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Organon and Co · Phase 3, Interventional, and Prevention
The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 720 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Genotype-confirmed heterozygous familial hypercholesterolemia with written documentation of the genetic diagnosis at the time of screening and LDL-C >=210 mg/dL (5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia, defined as LDL-C >=210 mg/dL (5.43 mmol/L) and at least one of the following:
Exclusion Criteria:
Drug: ezetimibe (plus simvastatin)
Drug: placebo (plus simvastatin)
oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Also known as: ZETIA, VYTORIN, SCH 58235, SCH 465981
tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint.
Time frame: 24 months
Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint.
Time frame: 24 months
Change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint.
Time frame: 24 months
Proportion of subjects developing new carotid artery plaques between baseline and endpoint.
Time frame: 24 months
Change in ultrasound-determined average carotid artery plus average common femoral artery IMT on a per subject basis between baseline and endpoint.
Time frame: 24 months
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Organon and Co