CompletedPhase 4

Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

1,140 participantsStarted 2005-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients With A Diagnosis Of Primary Hypercholesterolemia And * Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease \> 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease) * And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone Exclusion Criteria: \-

What they're measuring

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.

Timeframe: 6 weeks

Trial details

NCT IDNCT00652847

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-05

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