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Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

This study is currently recruiting participants.
Verified August 2012 by Gachon University Gil Medical Center
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01666041
First received: August 15, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hypertriglyceridemia
 Drug: placebo
Drug: fenofibrate/omega
Drug: fenofibrate
 Phase 4

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

Resource links provided by NLM:

Drug Information available for: Fenofibrate
U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
Active Comparator: fenofibrate/omega Drug: fenofibrate/omega
Active Comparator: fenofibrate Drug: fenofibrate

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

  • moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666041

Contacts
Contact: Kwang K Koh, MD,PhD kwangk@gilhospital.com

Locations
Korea, Republic of
Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Seung Han, MD         shhan@gilhospital.com    
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01666041     History of Changes
Other Study ID Numbers: GMC-201202
Study First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
insulin resistance

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013