- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01666041
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate
November 1, 2014 updated by: Kwang Kon Koh, Gachon University Gil Medical Center
The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Incheon, Korea, Republic of, 405-760
- Gil Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hypertriglyceridemia
Exclusion Criteria:
- moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
|
Active Comparator: fenofibrate/omega
|
|
Active Comparator: fenofibrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
flow-mediated dilation
Time Frame: 8 weeks of treatment
|
8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
insulin resistance
Time Frame: 8 weeks of treatment
|
8 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 16, 2012
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 1, 2014
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMC-201202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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