Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418834
• Other study ID #: 0653-112
• Secondary ID: MK0653-1122006_5
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: October 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 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient is age 65 or older

• Patient is willing to maintain cholesterol lowering diet

• Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion Criteria:

• A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study

• Patient is unlikely to be compliant in taking study medication

• Patient with chronic or unstable medical condition

• Patient is taking unstable doses of medication

• Patient drinks more than 2 alcoholic drinks per day

• Patient has elevations in certain laboratory values (CK, AST, ALT)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe and atorvastatin
ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
• atorvastatin
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
• Placebo (unspecified)
Placebo (unspecified) daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Zieve F, Wenger NK, Ben-Yehuda O, Constance C, Bird S, Lee R, Hanson ME, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe added to atorvastatin versus up titration of atorvastatin to 40 mg in Patients > or = 65 years of age (from the ZETia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12		Baseine and Week 12
Other	Percent Change From Baseline in Total Cholesterol (TC) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Total Cholesterol (TC) at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Triglycerides (TG) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Triglycerides (TG) at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12		Baseline and Week 12
Other	Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6		Baseline and Week 6
Other	Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12		Baseline and Week 12
Primary	Percent Change From Baseline in LDL-C at Week 6		Baseline and Week 6
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline and Week 12
Secondary	Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6		Week 6
Secondary	Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12		Week 12
Secondary	Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6		Week 6
Secondary	Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12		Week 12