Triglyceride Lowering Study

NCT ID: NCT00934219

Last Updated: 2009-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-12-31

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).

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 reduce blood pressure, cardiac events and mortality from congestive heart failure. There is strong scientific evidence that omega 3 fatty acids significantly reduce blood triglyceride levels while elevating high density lipoprotein cholesterol (HDL) levels. Fasting and non fasting hypertriglyceridemia have been associated with atherosclerosis, and coronary heart disease events, even in the absence of hypercholesterolemia. Severe hypertriglyceridemia (>2000 mg/dl) can also lead to acute hemorrhagic pancreatitis.

Currently, patients having very High TG are treated with Fibric acids (gemfibrozil, Tricor, Antara), and if hyperinsulinemic, with Glucophage. Lovaza (4g/day) has been shown to be effective and safe in lowering TG levels. There is no published data which indicates that Lovaza 8 or 12 g per day would have therapeutic effectiveness in further normalizing triglycerides in subjects on maximized triglyceride lowering and Lovaza 4 g per day. We hypothesize, based on our clinical experience that increasing Lovaza to 8 and then (if necessary) to 12 g/day would safely optimize triglycerides in subjects with primary hypertriglyceridemia who failed to normalize their triglycerides on optimal therapy including Lovaza 4 g/day.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose Lovaza

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

Group Type: ACTIVE_COMPARATOR

Omega-3-Acid Ethyl Esters

Intervention Type: DRUG

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).

Standard Dose

2 g twice a day

Group Type: ACTIVE_COMPARATOR

Omega-3-Acid Ethyl Esters

Intervention Type: DRUG

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).

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).

Intervention Type: DRUG

Other Intervention Names

LOVAZA

Eligibility 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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Jewish Hospital, Cincinnati, Ohio

OTHER

Sponsor Role: lead

Responsible Party

Jewish Hospital Cholesterol Center

Principal Investigators

Charles Glueck, MD

Role: PRINCIPAL_INVESTIGATOR

JEWISH HOSPITAL CHOLESTEROL CENTER

Locations

Jewish Hospital Cholesterol Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

LUANN SIEVE

Role: CONTACT

luann.sieve@healthall.com

(513)585-7951

Naila Goldenberg, MD

Role: CONTACT

naila.goldenberg@healthall.com

(513) 585-7950

Related Links

http://www.jewishhospitalcincinnati.com/cholesterol/Research/FREE_TRIGLYCERIDE_LOWERING_STUDY-2009.html

Free Triglycerides lowering study

Other Identifiers

TgLL8506

Identifier Type: -

Identifier Source: org_study_id