Phase 3 N=1,143 Randomized Double-blind Treatment

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

Hypercholesterolemia · Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00409773 ↗

Enrolled (actual)

1,143

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 — -36.5; -49.6; -39.4; -53.9 Percent Change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ezetimibe (+) simvastatin (Drug); Comparator: atorvastatin calcium (Drug); Comparator: Placebo (unspecified) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6	-36.5; -49.6; -39.4; -53.9; -46.0	<0.001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6	-26.5; -33.7; -28.3; -37.3; -32.8	<0.001 sig
SECONDARY Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6	-21.7; -23.3; -27.5; -29.5; -30.0	0.690
SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6	3.4; 6.8; 5.6; 8.8; 4.9	0.013 sig
SECONDARY Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6	-33.5; -43.8; -36.5; -48.3; -41.4	<0.001 sig
SECONDARY Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6	-17.7; -18.3; -21.6; -23.4; -22.7	0.809
SECONDARY Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6	-27.9; -37.2; -31.9; -41.1; -35.8	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6	0.8; 3.2; 1.0; 3.0; 1.4	0.042 sig
SECONDARY Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6	-28.1; -36.9; -31.5; -41.2; -35.3	<0.001 sig
SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6	-37.8; -51.8; -42.1; -56.6; -48.2	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6	-27.4; -38.4; -32.0; -41.9; -36.2	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6	-34.7; -46.2; -39.2; -51.2; -43.5	<0.001 sig
SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)	-37.1; -48.7; -36.9; -56.1; -45.8	—
SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)	-36.3; -50.1; -40.3; -53.2; -46.1	—
SECONDARY Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6	-16.8; -17.2; -22.4; -27.6; -30.0	0.420

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 Criteria

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

Exclusion Criteria

A condition which, in the opinion of the investigator, pose a risk to the patient or interfere 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 other lipid-altering medications
Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00409773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.