NCT00157924

Brief Summary

An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

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

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
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 7, 2024

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

September 7, 2005

Last Update Submit

June 5, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • LDL-C lowering efficacy

    6 weeks

Secondary Outcomes (1)

  • Safety

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

1\. simvastatin/ezetimibe 10/20mg

Drug: simvastatin (+) ezetimibe

2

ACTIVE COMPARATOR

2\. atorvastatin 10mg

Drug: atorvastatin

Interventions

simvastatin (+) ezetimibeDRUG

simvastatin (+) ezetimibe 10/20mg.

Also known as: MK0653A, Vytorin®
1
atorvastatinDRUG

atorvastatin 10mg

Also known as: Lipitor®
2

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of hypercholesterolemia
  • Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

You may not qualify if:

  • Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe, Simvastatin Drug CombinationAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

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

September 7, 2005

First Posted

September 12, 2005

Study Start

November 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 7, 2024

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share