NCT00090168

Brief Summary

A 6-week treatment study to compare the reduction in cholesterol of two drugs MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
435

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2004

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

August 25, 2004

Last Update Submit

August 12, 2024

Conditions

HypercholesterolemiaAtherosclerotic DiseaseCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • LDL-C lowering

Secondary Outcomes (1)

  • Total cholesterol (TC) lowering

Interventions

MK0653A , ezetimibe (+) simvastatinDRUG
Comparator: atorvastatinDRUG
Duration of Treatment: 6 weeksDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
\- Men and women greater than or equal to 18 years of age with elevated cholesterol levels and coronary heart disease (CHD), or atherosclerotic vascular disease may be eligible to participate in this study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Barrios V, Amabile N, Paganelli F, Chen JW, Allen C, Johnson-Levonas AO, Massaad R, Vandormael K. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract. 2005 Dec;59(12):1377-86. doi: 10.1111/j.1368-5031.2005.00714.x.

    PMID: 16351668BACKGROUND

MeSH Terms

Conditions

HypercholesterolemiaCoronary Disease

Interventions

EzetimibeSimvastatinDuration of Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

August 25, 2004

First Posted

August 27, 2004

Study Start

January 27, 2004

Primary Completion

October 20, 2004

Study Completion

November 10, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02