NCT00090298

Brief Summary

A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,815

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

August 25, 2004

Last Update Submit

August 12, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • LDL-C lowering efficacy after 6 weeks.

Secondary Outcomes (1)

  • Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.

Interventions

MK0653A, ezetimibe (+) simvastatinDRUG
Comparator: RosuvastatinDRUG

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Catapano AL, Davidson MH, Ballantyne CM, Brady WE, Gazzara RA, Tomassini JE, Tershakovec AM. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006 Oct;22(10):2041-53. doi: 10.1185/030079906X132721.

    PMID: 17022864BACKGROUND

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

August 25, 2004

First Posted

August 30, 2004

Study Start

April 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02