Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Treatments: Atorvastatin; Atorvastatin Calcium; Fenofibrate

Criteria

Inclusion Criteria:

1. 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).

2. 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.

3. Other inclusion criteria might apply

Exclusion Criteria:

1. TGs > 500 mg/dL.

2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.

3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.

4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.

5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.

6. History of pancreatitis.

7. Known allergy or sensitivity to statins or fibrates.

8. Poorly controlled hypertension.

9. Other exclusion criteria might apply.