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NCT01666041 Clinical Trial

Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Hypertriglyceridemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01666041
Other study ID # GMC-201202
Secondary ID
Status Completed
Phase Phase 4
First received August 15, 2012
Last updated November 1, 2014
Start date January 2012
Est. completion date July 2013

Study information
Verified date August 2012
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- hypertriglyceridemia

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo

• fenofibrate/omega

• fenofibrate

Locations
Country Name City State
Korea, Republic of Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary flow-mediated dilation 8 weeks of treatment No
Secondary insulin resistance 8 weeks of treatment No
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