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)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00652847

Collaborator

(none)

1,140

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: ezetimibe Drug: statins	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 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 ezetimibe 10 mg/day for a six week course of treatment. Other Names: Zetia® MK0653 Drug: statins patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
Active Comparator: Group 2 Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.	Drug: statins patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase

Arm

Intervention/Treatment

Experimental: group 1

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

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

Other Names:

Zetia®

MK0653

Drug: statins

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

Active Comparator: Group 2

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

Drug: statins

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

Outcome Measures

Primary Outcome Measures

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. [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00652847

Other Study ID Numbers:

0653-152
MK0653-152
2008_005

First Posted:

Apr 4, 2008

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Hypercholesterolemia

Ezetimibe

Study Results

No Results Posted as of Feb 18, 2022