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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ezetimibe and atorvastatin

atorvastatin

Placebo (unspecified)

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C at Week 6

Secondary Outcome Measures

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at 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

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

Full Information

NCT ID

NCT00418834

First Posted

January 3, 2007

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00418834

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1053 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ezetimibe and atorvastatin

Intervention Description

ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Intervention Description

Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo (unspecified)

Intervention Description

Placebo (unspecified) daily for 12 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline in LDL-C at Week 6

Time Frame

Baseline and Week 6

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time Frame

Baseline and Week 12

Title

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

Time Frame

Week 6

Title

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12

Time Frame

Week 12

Title

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

Time Frame

Week 6

Title

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

Time Frame

Week 12

Other Pre-specified Outcome Measures:

Title

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

Time Frame

Baseine and Week 12

Title

Percent Change From Baseline in Total Cholesterol (TC) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Total Cholesterol (TC) at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Triglycerides (TG) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Triglycerides (TG) at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

Time Frame

Baseline and Week 12

Title

Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6

Time Frame

Baseline and Week 6

Title

Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

20185012

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.

Results Reference

result

PubMed Identifier

24411003

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.

Results Reference

derived

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

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