NCT00762164

Brief Summary

The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 3, 2013

Completed
Last Updated

July 3, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

September 29, 2008

Results QC Date

April 16, 2013

Last Update Submit

April 19, 2013

Conditions

Hypercholesterolemia

Keywords

HypercholesterolemiaStatinsEzetimibe

Outcome Measures

Primary Outcomes (1)

  • LDL Cholesterol

    6 weeks

Secondary Outcomes (1)

  • Total Cholesterol

    6 weeks

Study Arms (2)

1Vytorin 10/80 divided into 4

ACTIVE COMPARATOR

Vytorin 10/80 divided into 4

Drug: Vytorin

Simvastatin

ACTIVE COMPARATOR

Simvastatin 20 milligrams

Drug: Simvastatin

Interventions

VytorinDRUG

Vytorin 10/80 split into 4

1Vytorin 10/80 divided into 4
SimvastatinDRUG

Simvastatin 20 milligrams

Simvastatin

Eligibility Criteria

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

You may qualify if:

  • Subjects with an LDL-cholesterol greater than 100 mg/dL
  • Patients willing and able to provide signed informed consent

You may not qualify if:

  • Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
  • Patients intolerant of statins
  • Patients receiving ezetimibe
  • Patients intolerant of ezetimibe
  • Patients receiving a niacin preparation
  • Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
  • Cancer undergoing active treatment
  • Creatinine clearance \< 50 ml/minute
  • Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
  • Participation in any clinical study within the last 30 days
  • Drug addition or alcohol abuse within the past 6 months
  • Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
  • Active use of macrolide antibiotics or verapamil
  • Consumption of grapefruit juice on a daily basis
  • Patients unwilling or unable to provide informed consent
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe, Simvastatin Drug CombinationSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Lawrence Baruch
Organization
Bronx VA Medical Center
lawrence.baruch@va.gov
718-584-9000

Study Officials

  • Lawrence Baruch, MD

    Bronx VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

March 1, 2007

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

July 3, 2013

Results First Posted

July 3, 2013

Record last verified: 2013-04

Locations

US(1)