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Lovaza · 3 trials · 3 indications
Primary Specific Aim To determine the effects of omega-3 fatty acid supplementation on urine protein excretion and surrogate markers of kidney injury including: serum beta-microglobulin and cystatin C (biomarkers of GFR) and urine neutrophil gelatinase-associated lipocain (NGAL a.k.a. lipocalin-2), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) (biomarkers of tubular reabsorption impairment and inflammation).
Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.
The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.
| Arm | Type | Description |
|---|---|---|
| Lovaza | EXPERIMENTAL | 4 grams per day |
| atorvastatin arm | ACTIVE_COMPARATOR | atorvastatin + placebo |
| Lovaza arm | EXPERIMENTAL | Lovaza + atorvastatin |
| Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza | EXPERIMENTAL | First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin |
| Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo | EXPERIMENTAL | First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo |
| Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin | EXPERIMENTAL | First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin |
| Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin | EXPERIMENTAL | First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin |
| Name | Type | Description |
|---|---|---|
| Lovaza (fish oil) | DIETARY_SUPPLEMENT | 4 grams per day |
| Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin | DRUG | Lovaza + atorvastatin |
| atorvastatin | DRUG | atorvastatin + placebo |
| Aspirin | DRUG | Aspirin 81mg tablet |
| Lovaza | DRUG | Lovaza 4 grams |
| Both Aspirin and Lovaza | DRUG | Lovaza 4 grams plus aspirin 81 mg |
| Placebo | OTHER | Capsule resembling fish oil and a tablet resembling aspirin |
Inclusion Criteria: * Participants have a diagnosis of diabetes (either oral medication or diet controlled) * Have an average systolic blood pressure (SBP) \<150 and diastolic blood pressure (DBP) \<90 mmHg * Have quantified proteinuria -- urine albumin/creatinine ratio of \> 17 mg/g (men) and \>25...
Lovaza plus atorvastatin refers to co-administration of Lovaza, an omega-3-acid ethyl esters product formerly known as Omacor, with atorvastatin. This combination has been studied in a Phase 3 trial in subjects with hypertriglyceridemia. Lovaza is developed by GSK plc.
Lovaza plus atorvastatin has been studied for hypertriglyceridemia, diabetes, and increased drug resistance. The Phase 3 trial NCT00435045 evaluated the efficacy and safety of Omacor co-administered with atorvastatin in subjects with hypertriglyceridemia. Other completed trials examined omega-3 fatty acid supplementation in diabetes-related kidney disease and aspirin resistance.
Lovaza is developed by GSK plc, which trades under the ticker GSK. The combination of Lovaza with atorvastatin has been investigated in clinical trials sponsored by GSK.
Lovaza plus atorvastatin has been studied in Phase 3 clinical development. The Phase 3 trial NCT00435045, which evaluated Omacor co-administered with atorvastatin in hypertriglyceridemia, is completed. No active trials are currently listed for this combination.
The combination has been evaluated in completed trials including NCT00435045, a Phase 3 study of Omacor co-administered with atorvastatin in hypertriglyceridemia with 245 participants. Other completed trials include NCT01092390 in diabetes-related kidney disease and NCT00771914 in aspirin resistance.
Yes, Lovaza was formerly known as Omacor. Both names refer to the same omega-3-acid ethyl esters product. The Phase 3 trial NCT00435045 used the name Omacor when evaluating co-administration with atorvastatin in subjects with hypertriglyceridemia.