NCT00276458

Brief Summary

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P25-P50 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 10, 2006

Completed
3 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
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2009

Completed
Last Updated

May 13, 2024

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

January 10, 2006

Results QC Date

December 18, 2008

Last Update Submit

May 7, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

    \[(6 week value - baseline value)/baseline value\]\*100%.

    6 weeks

Secondary Outcomes (11)

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

    6 weeks

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

    6 Weeks

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

    6 Weeks

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

    6 weeks

  • Percent Change From Baseline in Apolipoprotein B at Week 6

    6 Weeks

  • +6 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).

Drug: Comparator: atorvastatinDrug: Comparator: Placebo

2

EXPERIMENTAL

Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).

Drug: Comparator: ezetimibeDrug: Comparator: Placebo.

Interventions

Comparator: atorvastatinDRUG

Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks

1
Comparator: Placebo.DRUG

Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

2
Comparator: ezetimibeDRUG

Atorvastatin 20mg and ezetimibe 10mg tablets po qd (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 \>100 mg/dL \& on a stable dose of atorvastatin 20 mg

You may not qualify if:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin
  • Patient with diabetes or coronary heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.

    PMID: 19026302BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

194 out of 196 randomized patients took at least one dose of blinded study therapy and were included in the safety analysis

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
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 10, 2006

First Posted

January 13, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 13, 2024

Results First Posted

July 8, 2009

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share