Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Last updated: May 8, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Metabolic Syndrome

Metabolic Disorders

High Cholesterol (Hyperlipidemia)

Treatment

ezetimibe (+) simvastatin

Comparator: Placebo (unspecified)

Comparator: atorvastatin calcium

Clinical Study ID

NCT00409773
0653A-107
2006_527
  • Ages 18-79
  • All Genders

Study Summary

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia athigh risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dLdepending on their CHD risk category

Exclusion

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, pose a risk to the patient orinterfere with participating in the study

  • Patient is likely to be greater than 20% noncompliant in taking study medications

  • Patients with chronic medical conditions

  • Patients with unstable doses of medications

  • Pregnant or lactating women, women intending to become pregnant

  • Patient is currently receiving prescription therapy with statins or otherlipid-altering medications

  • Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newlydiagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (withthe exception of +/- 10 units of insulin)

Study Design

Total Participants: 1143
Treatment Group(s): 3
Primary Treatment: ezetimibe (+) simvastatin
Phase: 3
Study Start date:
January 01, 2007
Estimated Completion Date:
July 31, 2008