A Phase 4 interventional study of ezetimibe and statins in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Organon and Co · Phase 4, Interventional, and Treatment
To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose
1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.
This study's enrollment of 1,140 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-
group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.
Drug: ezetimibe · Drug: statins
Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.
Drug: statins
ezetimibe 10 mg/day for a six week course of treatment.
Also known as: Zetia®, MK0653
patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment.
Time frame: 6 weeks
No study locations are listed for this record.
The record gives a start of May 2005, a primary completion of May 2007 and a completion of May 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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.
Studies of the drug tested here: Ezetimibe