NCT01122355

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

11 months

First QC Date

May 12, 2010

Last Update Submit

May 28, 2010

Conditions

Hypertriglyceridemia With Low HDL-cholesterol

Outcome Measures

Primary Outcomes (1)

  • percent change of apoB/A1

    after 16 weeks of drug treatment

Study Arms (2)

niacin arm

ACTIVE COMPARATOR
Drug: lipid modification

fenofibrate arm

ACTIVE COMPARATOR
Drug: lipid modification

Interventions

lipid modificationDRUG

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

fenofibrate armniacin arm

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Triglyceride 150-500 mg/dL and HDL-cholesterol \< 45 mg/dL after 8 week dietary run in period
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sang Hak Lee

    professor of division of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 13, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 31, 2010

Record last verified: 2010-05