A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Groups Study Comparing the Efficacy and Safety of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia

Organon and Co0 sites392 target enrollmentApril 2006

ConditionsHypercholesterolemia

InterventionsEzetimibe with Simvastatin Placebo

Drugsezetimibe with simvastatin Ezetimibe with Simvastatin Placebo

Overview

Phase: Phase 3
Intervention: Ezetimibe with Simvastatin
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Enrollment: 392
Primary Endpoint: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

November 2006

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be \>=18 years and \<=75 years of age, male or female.
•Primary hypercholesterolemic subject with a plasma LDL cholesterol concentration \>3.64 mmol/L (140 mg/dL) to \<=6.3 mmol/L (250 mg/dL) using the Friedewald calculation; total cholesterol (TC) \>5.2 mmol/L (200 mg/dL) to \<12.7 mmol/L (500 mg/dL) and triglyceride concentrations of \<=3.99 mmol/L (350 mg/dL) should be met at the same time. At the time of recruitment (Visit 1), these values may be lower if the subject is on lipid-lowering therapy. (ie, prior to the start of lipid lowering drug washout) or may be higher at the start of dietary therapy.
•Liver transaminases (ALT, AST) \<=50% above the upper limit of normal, with no active liver disease and CK \<=50% above the upper limit of normal.
•Clinical laboratory tests (complete blood count \[CBC\], blood chemistries, urinalysis) must be within normal limits, or clinically acceptable to the investigator/sponsor.
•Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control.
•Subjects must be free of any clinically significant diseases other than hyperlipidemia that would interfere with study evaluations.
•Subjects must understand and be able to adhere to the dosing and visit schedules.
•Subject must agree to remain on a cholesterol-lowering diet for the duration of the study (according to China Adult Treatment Panel of High Blood Cholesterol).

Exclusion Criteria

•Subjects whose body mass index (BMI=weight \[kg\]/height2 \[m\]) is \>=30 kg/m2 at Visit 3 (Baseline Visit).
•Subjects who have known hypersensitivity to HMG CoA reductase inhibitors.
•Subjects who consume \>14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
•Any condition or situation, which in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
•Women who are pregnant or nursing.
•Subjects who have not observed the designated washout periods for any of the prohibited medications.
•Congestive heart failure defined by NYHA as Class III or IV.
•Uncontrolled cardiac arrhythmia.
•Myocardial infarction, coronary bypass surgery, or angioplasty within 6 months of study entry.
•Unstable or severe peripheral artery disease within 3 months of study entry.