Triglyceride Lowering Study
Status unconfirmed · Phase 4
Conditions studied: Hypertriglyceridemia
In brief
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).
Key facts
- Study ID
- NCT00934219
- Run by
- Jewish Hospital, Cincinnati, Ohio
- People needed
- 25
- Starts
- 2009-07-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2009-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- Absence of exclusionary criteria (see below).
You may not qualify if…
- Patients with known allergy to fish
- Hypertriglyceridemia secondary to alcoholism, exogenous estrogens, nephrotic syndrome, hemochromatosis, glycogen storage disease, uncontrolled diabetes, exogenous corticosteroids, Cushing's syndrome, uremia).
- Bleeding gastric or duodenal ulcers, active inflammatory bowel disease.
- Pregnancy
- Dementia
- Patients with bleeding diatheses
- Patients who are taking concomitant anticoagulants and other medications that affect bleeding time (e.g., warfarin, aspirin)
- Patients with significantly abnormal transaminases (above 3x of upper normal limit)or any history of liver disease
- Patients with conditions affecting the skin (e.g. malignancy, vasculitides) that may confound the skin exam.
Where it is running
- Jewish Hospital Cholesterol Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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