Recruiting

Triglyceride Lowering

Sponsor:

Jewish Hospital, Cincinnati, Ohio

Code:

NCT00934219

Conditions

Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Omega-3-Acid Ethyl Esters

Study Details

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 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).

Conditions

Hypertriglyceridemia

Study ID

NCT00934219

Start date

Jul, 2009

Status verified date

Jun, 2009

Completion date

Dec, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: High dose Lovaza

Lovaza 4 g twice a day, if not effective then 4 g 3 times a day

active comparator: Standard Dose

2 g twice a day

Interventions

Omega-3-Acid Ethyl Esters

LOVAZA, 1 g caps; High Dose Arm for 4 months, while on a standard therapy for hypertriglyceridemia (fibrates, +/-metformin). Standard Dose Arm for 3 months, while on a standard, unchanged therapy for hypertriglyceridemia (fibrates +/- metformin).

Primary outcome measure

  • triglycerides level [ Time Frame: 7 months ]

Central Contacts and Locations

Locations

Jewish Hospital Cholesterol Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Jewish Hospital, Cincinnati, Ohio

Last update posted

Jul 8, 2009

Last verified

Jun, 2009

Keywords

  • hypertriglyceridemia
  • triglycerides
  • familial hypertriglyceridemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish Hospital, Cincinnati, Ohio on 2009-07-08.