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)

Organon and Co1,140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,140

Conditions

Hypercholesterolemia

Interventions

ezetimibeDRUG

ezetimibe 10 mg/day for a six week course of treatment.

statinsDRUG

patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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