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

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: statins; Drug: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652847

0653-152

2008_005

MK0653-152

Details and patient eligibility

About

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

Enrollment: 1,140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,140 participants in 2 patient groups

group 1

Experimental group

Description:

group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.

Treatment:

Drug: ezetimibe

Drug: statins

Group 2

Active Comparator group

Description:

Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.

Treatment:

Drug: statins