- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092586
Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)
February 3, 2022 updated by: Organon and Co
A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level
The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The duration of treatment is 6 weeks.
Study Type
Interventional
Enrollment (Actual)
2904
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- High cholesterol levels that are identified by specific laboratory values
Exclusion Criteria:
- Active liver disease
- Any condition or situation which would interfere with participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percent change in LDL-C
|
Secondary Outcome Measures
Outcome Measure |
---|
Percentage of patients reaching NCEP ATP III target LDL-C levels
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pearson TA, Denke MA, McBride PE, Battisti WP, Brady WE, Palmisano J. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEP ATP III goals for LDL cholesterol in hypercholesterolemic patients: the ezetimibe add-on to statin for effectiveness (EASE) trial. Mayo Clin Proc. 2005 May;80(5):587-95. doi: 10.4065/80.5.587.
- Pearson T, Denke M, McBride P, Battisti WP, Brady WE, Palmisano J. Effectiveness of the addition of ezetimibe to ongoing statin therapy in modifying lipid profiles and attaining low-density lipoprotein cholesterol goals in older and elderly patients: subanalyses of data from a randomized, double-blind, placebo-controlled trial. Am J Geriatr Pharmacother. 2005 Dec;3(4):218-28.
- Pearson TA, Denke MA, McBride PE, Battisti WP, Gazzara RA, Brady WE, Palmisano J. Effectiveness of ezetimibe added to ongoing statin therapy in modifying lipid profiles and low-density lipoprotein cholesterol goal attainment in patients of different races and ethnicities: a substudy of the Ezetimibe add-on to statin for effectiveness trial. Mayo Clin Proc. 2006 Sep;81(9):1177-85. doi: 10.4065/81.9.1177.
- Denke M, Pearson T, McBride P, Gazzara RA, Brady WE, Tershakovec AM. Ezetimibe added to ongoing statin therapy improves LDL-C goal attainment and lipid profile in patients with diabetes or metabolic syndrome. Diab Vasc Dis Res. 2006 Sep;3(2):93-102. doi: 10.3132/dvdr.2006.020.
- Pearson TA, Ballantyne CM, Veltri E, Shah A, Bird S, Lin J, Rosenberg E, Tershakovec AM. Pooled analyses of effects on C-reactive protein and low density lipoprotein cholesterol in placebo-controlled trials of ezetimibe monotherapy or ezetimibe added to baseline statin therapy. Am J Cardiol. 2009 Feb 1;103(3):369-74. doi: 10.1016/j.amjcard.2008.09.090. Epub 2008 Oct 30.
- Thongtang N, Lin J, Schaefer EJ, Lowe RS, Tomassini JE, Shah AK, Tershakovec AM. Effects of ezetimibe added to statin therapy on markers of cholesterol absorption and synthesis and LDL-C lowering in hyperlipidemic patients. Atherosclerosis. 2012 Dec;225(2):388-96. doi: 10.1016/j.atherosclerosis.2012.09.001. Epub 2012 Sep 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
September 23, 2004
First Submitted That Met QC Criteria
September 27, 2004
First Posted (Estimate)
September 28, 2004
Study Record Updates
Last Update Posted (Actual)
February 15, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0653-040
- 2004_037
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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