Status:
UNKNOWN
Triglyceride Lowering Study
Lead Sponsor:
Jewish Hospital, Cincinnati, Ohio
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Lovaza contains Omega-3 fatty acids, the family of poly- unsaturated fatty acids. Omega-3 fatty acids stimulate blood circulation, increases the breakdown of fibrin, and additionally has been shown to...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00934219
Start Date
July 1 2009
End Date
December 1 2012
Last Update
July 8 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jewish Hospital Cholesterol Center
Cincinnati, Ohio, United States, 45229