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Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666041
First Posted: August 16, 2012
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kwang Kon Koh, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666041


Locations
Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Kwang Kon Koh, professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01666041     History of Changes
Other Study ID Numbers: GMC-201202
First Submitted: August 15, 2012
First Posted: August 16, 2012
Last Update Posted: November 4, 2014
Last Verified: August 2012

Keywords provided by Kwang Kon Koh, 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
Lipid Regulating Agents