Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
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
3 other identifiers
interventional
1,053
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 3, 2007
CompletedFirst Posted
Study publicly available on registry
January 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
October 6, 2009
CompletedMay 14, 2024
February 1, 2022
1.8 years
January 3, 2007
August 25, 2009
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in LDL-C at Week 6
Baseline and Week 6
Secondary Outcomes (5)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Week 6
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
Week 12
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
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
Other Outcomes (22)
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Baseline and Week 6
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Baseline and Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Baseline and Week 6
- +19 more other outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (2)
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.
PMID: 20185012RESULTConstance 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.
PMID: 24411003DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2007
First Posted
January 5, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 14, 2024
Results First Posted
October 6, 2009
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share