Differential Metabolic Effects of Fenofibrate and Fatty Acid | NCT01003847

Studies
Differential Metabolic Effects of Fenofibrate and Fatty Acid

NCT01003847

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

May 10, 2011Estimated

Enrollment

150Actual

Phase

Phase 4

Conditions

Hypertriglyceridemia

Interventions

fenofibrate, fatty acid, placebo

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

Oct 2010

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

Nov 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Oct 28, 2009

First Posted Date

Oct 29, 2009Estimated

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

May 9, 2011

Last Update Posted Date

May 10, 2011Estimated

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

Description Module

Brief Summary

The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Detailed Description

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fenofibrate	Active Comparator		Drug: fenofibrate, fatty acid, placebo
fatty acid	Active Comparator	drug	Drug: fenofibrate, fatty acid, placebo
Placebo	Active Comparator		Drug: fenofibrate, fatty acid, placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fenofibrate, fatty acid, placebo	Drug	fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment	Placebo fatty acid fenofibrate

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:

Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 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
D005227	Fatty Acids

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided