NCT00276484

Brief Summary

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Status
completed

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

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 13, 2009

Completed
Last Updated

May 14, 2024

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 11, 2006

Results QC Date

February 6, 2009

Last Update Submit

May 8, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C

    Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%

    Baseline and 6 weeks

Secondary Outcomes (12)

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

    Baseline and 6 weeks

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

    Baseline and 6 Weeks

  • Percent Change From Baseline to Week 6 in Total-Cholesterol

    Baseline and 6 Weeks

  • Percent Change From Baseline to Week 6 in Triglycerides (TG)

    Baseline and 6 Weeks

  • Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)

    Baseline and 6 Weeks

  • +7 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Atorvastatin 80 mg

Drug: atorvastatin

2

EXPERIMENTAL

Atorvastatin 40 mg + ezetimibe 10 mg

Drug: atorvastatinDrug: ezetimibe

Interventions

atorvastatinDRUG

Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks

1
ezetimibeDRUG

Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.

2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with LDL-C \>70 mg/dL \& on a stable dose of atorvastatin 40 mg

You may not qualify if:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23.

    PMID: 19026303BACKGROUND

  • Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136. doi: 10.1186/1476-511X-9-136.

    PMID: 21118495DERIVED

  • Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x.

    PMID: 20151997DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

AtorvastatinEzetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAzetidinesAzetines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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 11, 2006

First Posted

January 13, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

May 14, 2024

Results First Posted

April 13, 2009

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share