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)

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092586
• Other study ID #: 0653-040
• Secondary ID: 2004_037
• Status: Completed
• Phase: Phase 3
• Start date: September 2002
• Est. completion date: October 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2904
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MK0653, ezetimibe

• Comparator: statins

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in LDL-C
Secondary	Percentage of patients reaching NCEP ATP III target LDL-C levels