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

Metabolic Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409773
• Other study ID #: 0653A-107
• Secondary ID: 2006_527
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: July 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1143
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia
• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• ezetimibe (+) simvastatin
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
• Comparator: atorvastatin calcium
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
• Comparator: Placebo (unspecified)
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6		Baseline and 6 weeks
Secondary	Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)		Baseline and 6 Weeks
Secondary	Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6		Baseline and 6 Weeks