Triglyceride Lowering Study (TGLL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Jewish Hospital, Cincinnati, Ohio.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier:
NCT00934219
First received: July 7, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hypertriglyceridemia
Drug: Omega-3-Acid Ethyl Esters
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Related Decrease in Triglycerides in Patients With Hypertriglyceridemia and Treated With Lovaza.

Resource links provided by NLM:


Further study details as provided by Jewish Hospital, Cincinnati, Ohio:

Primary Outcome Measures:
  • triglycerides level [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: July 7, 2009
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 26, 2014