mixed dyslipidemia MedDRA version: 8.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Trade Name: Omacor
Pharmaceutical Form: Capsule, soft
CAS Number: 25378272
Other descriptive name: EICOSAPENTAENOIC ACID
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Provident Clinical Research & Consulting, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women ages 18-79 years, inclusive. 2. LDL-C above ATP III goal (average of weeks -2 and -1 values) after discontinuation of any lipid-altering therapies at visit 1 (week -5). 3. Fasting TG value 200 to 600 mg/dL, inclusive (average of values obtained at weeks -2 and -1), after discontinuation of any lipid-altering therapies at visit 1 (week -5). 4. Willing to maintain the Therapeutic Lifestyle Changes (TLC) diet and current physical activity level throughout the trial. 5. If a smoker, the subject has no plans to change smoking habits during the study period. 6. Women who have had a hysterectomy, tubal ligation or who are post-menopausal for at least one year prior to the study may be enrolled. Women of childbearing potential who are not pregnant, not planning to become pregnant during the study period, and not lactating may be enrolled if they are using a medically acceptable contraceptive program initiated at least two months prior to study entry and continued during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use after Visit 1 (screening) and during the treatment period of any non-study- lipid-altering drugs, including statins, bile acid sequestrants, cholesterol absorption inhibitors, or fibrates. 2. Use after Visit 1 (screening) and during the treatment period of any non-study-related omega-3 fatty acid supplements (e.g., flaxseed, fish, or algal oils) or enriched foods (consumption of up to two servings per week of fish is acceptable). 3. Use after Visit 1 (screening) and during the treatment period of any supplement known to alter lipid metabolism, including but not limited to: sterol/stanol products; dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplement per day); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >200 mg/d (or others at the discretion of the investigator). 4. History of a cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure in the six months prior to Visit 1 (screening). 5. BMI >40.0 kg/m2 6. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1 (screening). 7. Poorly controlled diabetes mellitus (HbA1C >9.0% at Visit 1) or diabetes mellitus requiring insulin therapy. 8. Known lipoprotein lipase impairment or deficiency or apo C-II deficiency or familial dysbetalipoproteinemia. (Type III hyperlipidemia). 9. History of pancreatitis. 10. History of allergy or sensitivity to statins [or any other hydroxymethylglutaryl Coenzyme A (HMG-CoA) reductase inhibitors], omega-3 fatty acids (or any other lipid-regulating agents) or fish. 11. Concomitant use of cyclosporine, itraconazole, ketoconazole, erythromycin, azithromycin, clarithromycin, human immunodeficiency virus (HIV) protease inhibitors, amiodarone, verapamil, telithromycin, digoxin, nefazodone, warfarin, or danazol. 12. Oral or systemic use of corticosteroids, or topical, inhaled, intranasal or dermal use of more than 1500 micrograms (µg) daily. 13. Concomitant use of phenytoin. 14. Chronic use of androgens. 15. Use of cyclic sex hormone therapy or cyclic oral contraceptives within 2 months of Visit 1 (screening) or during the study. 16. Unstable use (less than two months prior to visit 1) of medications for hypertension, diabetes mellitus, or hypothyroidism. 17. Use after Visit 1 (screening) of weight loss drugs (including over-the-counter) or programs during the trial. 18. Current symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis. 19. Serum transaminase(s) (aspartate aminotransferase or alanine aminotransferase) levels >1.5 x upper limits of normal (ULN) at Visit 1 (screening). 20. Serum creatinine level =2.0 mg/dL at Visit 1 (screening). 21. Poorly controlled hypertension, defined as resting blood pressure =160 mm Hg systolic and/or =100 mm Hg diastolic at two consecutive visits prior to visit 4. 22. Current or recent history (past 12 months) of drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week. 23. Participation in another clinical trial or exposure to any investigational agent within 30 days prior to Visit 1 (screening). 24. Recent history (within six months) or current significant renal, pulmonary, hepatic, biliary, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the effect of Simvastatin 20 mg/d plus Omacor 4 g/d compared to Simvastatin 20 mg/d plus placebo on the percent change from baseline in non-HDL-C;Secondary Objective: The secondary objectives of this clinical trial are to evaluate the effect of Simvastatin 20 mg/d plus Omacor 4 g/d compared to Simvastatin 20 mg/d plus placebo on the percent change from baseline in LDL-C, TG, TC, VLDL-C, HDL-C, TC:HDL-C and TG:HDL-C ratios and Apo A1 and B.;Primary end point(s): The primary outcome variable will be the percent change from baseline in non-HDL-C. Baseline will be considered the average of values collected at weeks -2, -1 and 0. On-treatment values will be average of values collected at weeks 5 and 6 for period 1, and the average of values collected at weeks 11 and 12 for period 2. | — |
Countries
Netherlands
Outcome results
None listed