NCT00092716

Brief Summary

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
655

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

September 23, 2004

Last Update Submit

August 12, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

Secondary Outcomes (2)

  • Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C

  • Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

Interventions

MK0653, ezetimibe / Duration of Treatment: 28 weeksDRUG
Comparator: atorvastatin / Duration of Treatment: 28 weeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Elevated cholesterol levels

You may not qualify if:

  • Liver disease
  • Unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94. doi: 10.1016/j.amjcard.2004.02.060.

    PMID: 15194018BACKGROUND

  • McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.

    PMID: 16369229BACKGROUND

  • Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.

    PMID: 16004682BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeDuration of Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2004

First Posted

September 28, 2004

Study Start

May 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

August 15, 2024

Record last verified: 2022-02