Triglyceride Lowering Study (TGLL)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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 |
Inclusion Criteria:
- 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 Criteria:
- 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.
-
Contacts and Locations| Contact: LUANN SIEVE | (513)585-7951 | luann.sieve@healthall.com |
| Contact: Naila Goldenberg, MD | (513) 585-7950 | naila.goldenberg@healthall.com |
| United States, Ohio | |
| Jewish Hospital Cholesterol Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| 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 May 19, 2013