NCT01660945

Brief Summary

The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 4, 2014

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 8, 2012

Last Update Submit

November 1, 2014

Conditions

Hypercholesterolemia

Keywords

statins, insulin resistance

Outcome Measures

Primary Outcomes (1)

  • flow-mediated dilation

    8 weeks of treatment

Secondary Outcomes (1)

  • insulin resistance

    8 weeks of treatment

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

vytorin 10

ACTIVE COMPARATOR

vytorin 10 mg

Drug: vytorin

vytorin 20

ACTIVE COMPARATOR

vytorin 20 mg

Drug: vytorin

Interventions

placeboDRUG
placebo
vytorinDRUG
vytorin 10vytorin 20

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypercholesterolemia

You may not qualify if:

  • overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center

Incheon, 405-760, South Korea

Location

MeSH Terms

Conditions

HypercholesterolemiaInsulin Resistance

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 9, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

November 4, 2014

Record last verified: 2012-08

Locations

KR(1)