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Triglyceride Lowering Study (TGLL)

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ClinicalTrials.gov Identifier: NCT00934219
Recruitment Status : Unknown
Verified June 2009 by Jewish Hospital, Cincinnati, Ohio.
Recruitment status was:  Recruiting
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Omega-3-Acid Ethyl Esters Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Related Decrease in Triglycerides in Patients With Hypertriglyceridemia and Treated With Lovaza.
Study Start Date : July 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: High dose Lovaza
Lovaza 4 g twice a day, if not effective then 4 g 3 times a day
Drug: 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).
Other Name: LOVAZA
Active Comparator: Standard Dose
2 g twice a day
Drug: 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).
Other Name: LOVAZA


Outcome Measures

Primary Outcome Measures :
  1. triglycerides level [ Time Frame: 7 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934219


Contacts
Contact: LUANN SIEVE (513)585-7951 luann.sieve@healthall.com
Contact: Naila Goldenberg, MD (513) 585-7950 naila.goldenberg@healthall.com

Locations
United States, Ohio
Jewish Hospital Cholesterol Center Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Jewish Hospital, Cincinnati, Ohio
GlaxoSmithKline
Investigators
Principal Investigator: Charles Glueck, MD JEWISH HOSPITAL CHOLESTEROL CENTER
More Information

Additional Information:
Responsible Party: Charles Glueck, MD Medical director of Cholesterol Center, Jewish Hospital Cholesterol Center
ClinicalTrials.gov Identifier: NCT00934219     History of Changes
Other Study ID Numbers: TgLL8506
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: June 2009

Keywords provided by Jewish Hospital, Cincinnati, Ohio:
hypertriglyceridemia
triglycerides
familial hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases