NCT00092638

Brief Summary

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

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, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

September 23, 2004

Last Update Submit

August 12, 2024

Conditions

HypercholesterolemiaCoronary Disease

Keywords

Elevated Cholesterol

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.

Secondary Outcomes (1)

  • Safety and tolerability.

Interventions

MK0653, ezetimibeDRUG
Comparator: ezetimibe, placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with elevated cholesterol and coronary heart disease

You may not qualify if:

  • Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cruz-Fernandez JM, Bedarida GV, Adgey J, Allen C, Johnson-Levonas AO, Massaad R. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. Int J Clin Pract. 2005 Jun;59(6):619-27. doi: 10.1111/j.1368-5031.2005.00565.x.

    PMID: 15924587BACKGROUND

MeSH Terms

Conditions

HypercholesterolemiaCoronary Disease

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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 27, 2004

Study Start

May 1, 2003

Primary Completion

July 1, 2004

Study Completion

August 1, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02