Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Completed · Phase 2
Conditions studied: Dyslipidemia
In brief
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Key facts
- Study ID
- NCT00504829
- Run by
- Veloxis Pharmaceuticals
- People needed
- 220
- Starts
- 2007-07-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2020-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL).
- Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day.
- Other inclusion criteria might apply
You may not qualify if…
- TGs > 500 mg/dL.
- History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
- Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
- Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
- Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
- History of pancreatitis.
- Known allergy or sensitivity to statins or fibrates.
- Poorly controlled hypertension.
- Other exclusion criteria might apply.
Where it is running
- Radiant Research, 515 N State Street, Suite 2700 — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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