Vascular and Metabolic Effects of Fenofibrate/Omega vs Fe... | NCT01666041

Studies
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

NCT01666041

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Hypertriglyceridemia

Interventions

placebo
fenofibrate/omega
fenofibrate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Aug 15, 2012

First Submission Date that Met QC Criteria

Aug 15, 2012

First Posted Date

Aug 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwang Kon Koh, professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	placebo	Drug: placebo
fenofibrate/omega	Active Comparator	fenofibrate/omega	Drug: fenofibrate/omega
fenofibrate	Active Comparator	fenofibrate	Drug: fenofibrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug		placebo
fenofibrate/omega

Measure	Description	Time Frame
flow-mediated dilation		8 weeks of treatment

Measure	Description	Time Frame
insulin resistance		8 weeks of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hypertriglyceridemia

Exclusion Criteria:

moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gil Medical Center		Incheon		405-760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011345	Fenofibrate

Ancestor Terms

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided