A Multicenter, Double-blind, Randomized, Active-controlled Parallel Groups Study Comparing The Efficacy and Safety of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg Vs Simvastatin Or Ezetimibe Alone in Subjects With Primary Hypercholesterolemia

Organon and Co0 sites240 target enrollmentJune 1, 2004

ConditionsHypercholesterolemia

InterventionsEzetimibe + Simvastatin Simvastatin Ezetimibe

DrugsEzetimibe + Simvastatin Simvastatin Ezetimibe

Overview

Phase: Phase 3
Intervention: Ezetimibe + Simvastatin
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Enrollment: 240
Primary Endpoint: Percent change from baseline in LDL-C concentration.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double blind; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.

Registry

clinicaltrials.gov

Start Date

June 1, 2004

End Date

February 1, 2005

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
•Subjects must be \>= 18 years and \<= 75 years of age.
•Subjects with Primary Hypercholesterolemia must be finished the Lab test listed below and the results must be available at the time of randomization at Visit 3 (Baseline Visit).
•LDL-C concentration \> 3.64 mmol/L (140mg/dL) to \<= 6.3 mmol/L (250 mg/dL) using the Friedewald calculation
•Total cholesterol (TC) \> 5.2mmol/L (200mg/dL) to \< 12.7mmol/L (500mg/dL)
•Triglyceride concentrations of \<= 3.99 mmol/L (350 mg/dL)
•Liver transaminases (ALT, AST) must be within normal limits, with no active liver disease and CK \< 50% above the upper limit of normal
•Clinical laboratory tests (CBC, blood chemistries, urinalysis) must be within normal limits
•Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
•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 (e.g. medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).

Exclusion Criteria

•Subjects whose body mass index (BMI = weight \[kg\]/height2 \[m\]) is \>= 30 Kg/m\^2 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 outlined in protocol
•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.