Clinical trial NCT00418834: Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 1053
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent Change From Baseline in LDL-C at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
timeFrame: Week 6
measure: Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 6
measure: 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
timeFrame: Week 12
Other outcomes:
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
timeFrame: Baseine and Week 12
measure: Percent Change From Baseline in Total Cholesterol (TC) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Total Cholesterol (TC) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Triglycerides (TG) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Triglycerides (TG) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6
timeFrame: Baseline and Week 6
measure: Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12
timeFrame: Baseline and Week 12
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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 in the ELDerly [ZETELD] study). Am J Cardiol. 2010 Mar 1;105(5):656-63. doi: 10.1016/j.amjcard.2009.10.029. Epub 2009 Dec 24.
citation: Constance C, Ben-Yehuda O, Wenger NK, Zieve F, Lin J, Hanson ME, Lowe RS, Tershakovec AM. Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects >/=65 years. Lipids Health Dis. 2014 Jan 13;13:13. doi: 10.1186/1476-511X-13-13.