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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00652847
First received: April 1, 2008
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: ezetimibe
Drug: statins
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 1140
Study Start Date: May 2005
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652847

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652847     History of Changes
Other Study ID Numbers: 0653-152, MK0653-152, 2008_005
Study First Received: April 1, 2008
Last Updated: May 2, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014