Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol

Hypertriglyceridemia With Low HDL-cholesterol Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122355
• Other study ID #: 4-2008-0530
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2010
• Last updated: May 28, 2010
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2010
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Hypertriglyceridemia With Low HDL-cholesterol

Intervention

Drug:
• lipid modification
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change of apoB/A1		after 16 weeks of drug treatment	No