NCT00092690

Brief Summary

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,902

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 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

June 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

September 23, 2004

Last Update Submit

May 8, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Plasma LDL-C averaged across all doses after 6 weeks

Secondary Outcomes (1)

  • Plasma LDL-C for each dose; plasma HDL-C averaged across all doses

Interventions

MK0653A, ezetimibe (+) simvastatinDRUG
Comparator: atorvastatinDRUG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated cholesterol

You may not qualify if:

  • Unstable medical conditions or significant heart problems within 3 months prior to first study visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005 Mar;149(3):464-73. doi: 10.1016/j.ahj.2004.11.023.

    PMID: 15864235BACKGROUND

  • Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.

    PMID: 17560879BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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 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 23, 2004

First Posted

September 28, 2004

Study Start

June 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

May 10, 2024

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share