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)

NCT00652847 | Completed Phase 4

• 3 other identifiers: 0653-152MK0653-1522008_005
• Study Type: interventional
• Target: 1,140
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group 1

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Drug: statins

Interventions

ezetimibe DRUG

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

Also known as: Zetia®, MK0653

group 1

statins DRUG

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

Group 2; group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Shekhar Pandey A, Bissonnette S, Boukas S, Rampakakis E, Sampalis JS. Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial. Arch Med Sci. 2011 Oct;7(5):767-75. doi: 10.5114/aoms.2011.25550. Epub 2011 Nov 8.

  PMID: 22291820 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: May 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: August 15, 2024

Record last verified: 2022-02