Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate
1 other identifier
interventional
120
1 country
1
Brief Summary
The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
1 active site
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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 4, 2014
August 1, 2012
1.1 years
August 15, 2012
November 1, 2014
Conditions
Keywords
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 COMPARATORplacebo
fenofibrate/omega
ACTIVE COMPARATORfenofibrate/omega
fenofibrate
ACTIVE COMPARATORfenofibrate
Interventions
Eligibility Criteria
You may qualify if:
- hypertriglyceridemia
You may not qualify if:
- moderate or severe hypertension, uncontrolled diabetes (HbA1c \> 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gil Medical Center
Incheon, 405-760, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 15, 2012
First Posted
August 16, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2013
Study Completion
July 1, 2013
Last Updated
November 4, 2014
Record last verified: 2012-08