NCT00395603

Brief Summary

To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
550

participants targeted

Target at P25-P50 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3 cardiovascular-diseases

Status
terminated

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

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

November 2, 2006

Last Update Submit

August 12, 2024

Conditions

Cardiovascular DiseasesDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction in ldl-c at end-point after 6 weeks.

Interventions

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 WeeksDRUG
Comparator: atorvastatin / Duration of Treatment: 6 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Greater than 18 years of age
  • Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
  • Existing coronary heart disease and cholesterol \> 4.0 mmol/l

You may not qualify if:

  • Uncontrolled diabetes
  • Elevated liver function tests
  • Elevated creatine kinase (ck)
  • Triglycerides (tg) \> 4.5 mmol/l
  • Drug or alcohol dependency within 6 months prior to visit 1
  • Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
  • Woman of childbearing potential not using an acceptable method of birth control
  • Women who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus

Interventions

EzetimibeSimvastatinDuration of Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 3, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 15, 2024

Record last verified: 2022-02