Triglyceride Lowering Study

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Lovaza is a special fish oil concentrate, that prescribed at 4 g a day to reduce certain fat (triglycerides) levels in blood.Our goal is to study how Lovaza at doses of 4, 8, and 12 grams per day will reduce fats in the blood of the patients with very high level of triglycerides. Our hypothesis is that patients with very high triglycerides will respond more with higher doses of Lovaza (8 g per day and then 12 g per day).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jewish Hospital, Cincinnati, Ohio
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

1. Primary hypertriglyceridemia with fasting TG levels >1000 mg/dl, and persistence of TG levels > 500 mg/dl despite maximal TG lowering therapy for 1 month, including Lovaza 4 g/day, fibric acids, and, where indicated, Glucophage for treatment of hyperinsulinemia.

2. Patients with mild to moderately impaired renal function should be initiated on TRICOR 48 mg and patients with severe renal impairment should not be given TRICOR.

3. Absence of exclusionary criteria (see below).

Exclusion Criteria:

1. Patients with known allergy to fish

2. Hypertriglyceridemia secondary to alcoholism, exogenous estrogens, nephrotic syndrome, hemochromatosis, glycogen storage disease, uncontrolled diabetes, exogenous corticosteroids, Cushing's syndrome, uremia).

3. Bleeding gastric or duodenal ulcers, active inflammatory bowel disease.

4. Pregnancy

5. Dementia

6. Patients with bleeding diatheses

7. Patients who are taking concomitant anticoagulants and other medications that affect bleeding time (e.g., warfarin, aspirin)

8. Patients with significantly abnormal transaminases (above 3x of upper normal limit)or any history of liver disease

9. Patients with conditions affecting the skin (e.g. malignancy, vasculitides) that may confound the skin exam.

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