NCT00652717

Brief Summary

Collecting local data, safety and experience trial.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

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

February 1, 2005

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

14 days

First QC Date

April 1, 2008

Last Update Submit

August 12, 2024

Conditions

Cardiovascular Disorder

Outcome Measures

Primary Outcomes (1)

  • LDL levels

    42 Days

Secondary Outcomes (2)

  • Safety measures

    42 days

  • Total cholesterol levels.

    42 Days

Study Arms (2)

1

EXPERIMENTAL

arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician).

Drug: EzetimibeDrug: simvastatin

2

ACTIVE COMPARATOR

arm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.

Drug: simvastatin

Interventions

EzetimibeDRUG

Ezetimibe 10 mg daily for 42 days.

Also known as: Ezetrol®, Zetia®, MK0653
1
simvastatinDRUG

simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.

Also known as: Zocor®, MK0733
12

Eligibility Criteria

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

You may qualify if:

  • Patients; Post Acute Coronary Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

EzetimibeSimvastatin

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

February 1, 2005

Primary Completion

February 15, 2005

Study Completion

August 4, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02