Back to resultsComparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
Primary Purpose
Hypertriglyceridemia With Low HDL-cholesterol
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lipid modification
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia With Low HDL-cholesterol
Eligibility Criteria
Inclusion Criteria:
- Triglyceride 150-500 mg/dL and HDL-cholesterol < 45 mg/dL after 8 week dietary run in period
- 20-79 years old
Exclusion Criteria:
- Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug
- History of cerebrovascular or cardiovascular diseases
- Creatinine > 2.0 mg/dL
- Transaminase > 2x upper limit of normal
- Gall bladder disease
- Cancer
- Pregnant or breast feeding women
- History of adverse events associated with test drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
niacin arm
fenofibrate arm
Arm Description
Outcomes
Primary Outcome Measures
percent change of apoB/A1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01122355
Brief Title
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia With Low HDL-cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
niacin arm
Arm Type
Active Comparator
Arm Title
fenofibrate arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lipid modification
Intervention Description
1) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks
Primary Outcome Measure Information:
Title
percent change of apoB/A1
Time Frame
after 16 weeks of drug treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Triglyceride 150-500 mg/dL and HDL-cholesterol < 45 mg/dL after 8 week dietary run in period
20-79 years old
Exclusion Criteria:
Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug
History of cerebrovascular or cardiovascular diseases
Creatinine > 2.0 mg/dL
Transaminase > 2x upper limit of normal
Gall bladder disease
Cancer
Pregnant or breast feeding women
History of adverse events associated with test drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hak Lee
Organizational Affiliation
professor of division of Cardiology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
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