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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00652847
First received: April 1, 2008
Last updated: May 13, 2008
Last verified: May 2008
History of Changes
  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:

MedlinePlus related topics: Cholesterol Statins
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00652847     History of Changes
Other Study ID Numbers: 2008_005, MK0653-152
Study First Received: April 1, 2008
Last Updated: May 13, 2008
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on May 23, 2013