NCT00157911

Brief Summary

Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 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

December 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

September 7, 2005

Last Update Submit

August 12, 2024

Conditions

Hypercholerolemia

Outcome Measures

Primary Outcomes (1)

  • LDL-C

Secondary Outcomes (1)

  • TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio

Interventions

MK0653; ezetimibe / Duration of Treatment: 12 weeksDRUG
Comparator: simvastatin / Duration of Treatment: 12 weeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Korean males or females at least 18 years of age with hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bae JW, Kim HS, Lee SC, Han KH, Jeon ES. The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia. Korean J Med. 2005;68(5):487-497 [in Korean].

    RESULT

MeSH Terms

Interventions

EzetimibeDuration of Therapy

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic 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

September 7, 2005

First Posted

September 12, 2005

Study Start

December 1, 2002

Primary Completion

October 1, 2003

Study Completion

December 1, 2003

Last Updated

August 15, 2024

Record last verified: 2022-02