HypertriglyceridemiaPhase 4TGLLNCT00934219
Triglyceride Lowering Study
A Phase 4 study testing Omega-3-Acid Ethyl Esters in people with Hypertriglyceridemia, run by Jewish Hospital, Cincinnati, Ohio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Omega-3-Acid Ethyl Esters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jewish Hospital Cholesterol Center
Cincinnati, Ohio, 45229
About this study
Official title: Dose Related Decrease in Triglycerides in Patients With Hypertriglyceridemia and Treated With Lovaza.
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).
Read the 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
- Being tested
- Omega-3-Acid Ethyl Esters
- Keywords
- hypertriglyceridemia, triglycerides, familial hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia, Hyperlipoproteinemia Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-Acid Ethyl EstersDrug
Also called LOVAZA
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).
| Study group | Role | What they receive |
|---|---|---|
| High dose Lovaza | Active comparator | Lovaza 4 g twice a day, if not effective then 4 g 3 times a day Receives: Drug: Omega-3-Acid Ethyl Esters |
| Standard Dose | Active comparator | 2 g twice a day Receives: Drug: Omega-3-Acid Ethyl Esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
triglycerides level
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish Hospital, Cincinnati, Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Charles Glueck, MD, Principal investigator, JEWISH HOSPITAL CHOLESTEROL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934219
- Sponsor's protocol ID
- TgLL8506
- Acronym
- TGLL
- Status last verified
- Jun 2009
- First submitted
- 7 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Related Decrease in Triglycerides in Patients With Hypertriglyceridemia and Treated With Lovaza.
- ClinicalTrials.gov ID
- NCT00934219
- Acronym / sponsor ID
- TGLL / TgLL8506
- Conditions
- Hypertriglyceridemia
- Keywords
- hypertriglyceridemia, triglycerides, familial hypertriglyceridemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jewish Hospital, Cincinnati, OhioUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Lovaza | Active comparator | Drug: Omega-3-Acid Ethyl EstersLovaza 4 g twice a day, if not effective then 4 g 3 times a day |
| Standard Dose | Active comparator | Drug: Omega-3-Acid Ethyl Esters2 g twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3-Acid Ethyl EstersAlso: LOVAZALOVAZA, 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). | Drug | High dose Lovaza, Standard Dose |
Primary outcome
triglycerides level
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
- Free Triglycerides lowering studyLink provided by the sponsor.
Related trials for Hypertriglyceridemia
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
Active, not recruitingPhase 3
A Study of SHR-1918 In Participants With Hypertriglyceridemia
Hypertriglyceridemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Glueck, MD principal investigator
JEWISH HOSPITAL CHOLESTEROL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3-Acid Ethyl Esters in people with Hypertriglyceridemia, run by Jewish Hospital, Cincinnati, Ohio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUANN SIEVE ((513)585-7951, luann.sieve@healthall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
triglycerides level (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.