NCT00166504

Brief Summary

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 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 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 5, 2008

Completed
Last Updated

May 22, 2024

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

September 9, 2005

Results QC Date

October 13, 2008

Last Update Submit

May 8, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • LDL-C Lowering Efficacy

    LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

    6 weeks

Study Arms (2)

Vytorin

EXPERIMENTAL

Ezetimibe 10 mg/Simvastatin 20 mg

Drug: ezetimibe (+) simvastatin

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 10 mg

Drug: atorvastatin

Interventions

ezetimibe (+) simvastatinDRUG

simvastatin/ezetimibe 10/20 mg

Also known as: MK0653A, Vytorin®
Vytorin
atorvastatinDRUG

atorvastatin 10 mg

Also known as: Lipitor®
Atorvastatin

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of hypercholesterolemia
  • LDL-C \>/= 130 mg/dL but \</=250 mg/dL and triglyceride (TG) \</= 350 mg/dL
  • National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

You may not qualify if:

  • Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 22, 2024

Results First Posted

November 5, 2008

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share