Triglyceride Lowering Study
TGLL
Dose Related Decrease in Triglycerides in Patients With Hypertriglyceridemia and Treated With Lovaza.
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 8, 2009
June 1, 2009
3 years
July 7, 2009
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
triglycerides level
7 months
Study Arms (2)
High dose Lovaza
ACTIVE COMPARATORLovaza 4 g twice a day, if not effective then 4 g 3 times a day
Standard Dose
ACTIVE COMPARATOR2 g twice a day
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jewish Hospital, Cincinnati, Ohiolead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Jewish Hospital Cholesterol Center
Cincinnati, Ohio, 45229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Glueck, MD
JEWISH HOSPITAL CHOLESTEROL CENTER
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 8, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
July 8, 2009
Record last verified: 2009-06