NCT00651560

Brief Summary

This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

March 31, 2008

Last Update Submit

August 12, 2024

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals.

    After 4 weeks treatment

Secondary Outcomes (1)

  • To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals.

    After 4 weeks treatment

Interventions

ezetimibe (+) simvastatinDRUG

ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.

Also known as: Vytorin®, MK0653A

Eligibility Criteria

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

You may qualify if:

  • Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form.

You may not qualify if:

  • Any Another Kind Of Contraindication For Use Of Statins
  • Hypersensitivity To Any Of The Active Ingredients
  • Increased Serum Hepatic Enzymes (Over 3 Times Only)
  • Patients With Severe Hepatic Insufficiency
  • Women who are Pregnant or Potentially Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 3, 2008

Study Start

November 1, 2005

Primary Completion

December 23, 2005

Study Completion

December 23, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02