a study to evaluate the lipid regulating effects of tria-662

Conditions: Hyperlipidemia

Summary: the purpose of this study is to determine the effectiveness and safety of tria-662 (also known as 1-mna) in treating elevated triglyceride levels in patients not receiving lipid lowering treatment. this study will determine the effects of tria-662 on commonly measured blood fats that are known to be important in the prevention of vascular disease.

this is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (tg) \> 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg tria-662 or 90 mg tria-662 three times daily for twelve weeks. lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age at the time of informed consent (women of childbearing potential must be practicing adequate contraception) * patients with mean serum tg \> 200 mg/dl (2.26 mmol/l) and \< 700 mg/dl (7.91 mmol/l) as measured at 2 sequential visits during the dietary controlled baseline period (visits 2 and 3 or visits 3 and 3a) and having lower level within 25% of upper level (higher value minus lower value)/higher value \< 0.25) * patients willing and able to sign an informed consent form and follow the protocol exclusion criteria: * patients who are pregnant or nursing * patients with evidence of hepatic dysfunction \[alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 1.5 times the upper limit of normal (uln), bilirubin greater than 1.5 times uln, or cirrhosis\] or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase * patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l or hba1c above 10%) as measured during the baseline phase * patients with hypothyroidism that is not treated or not stable for at least 6 months prior to study entry * patients with uncontrolled hypertension (systolic blood pressure above 160 mm hg and/or diastolic blood pressure above 110 mm hg) * patients with systolic blood pressure above 140 mm hg and three or more of the following cardiovascular risk factors: * current cigarette smoker * hdl-c \< 40 mg/dl (1.04 mmol/l) * coronary heart disease in male first degree relative \< 55 years of age * coronary heart disease in female first degree relative \< 65 years of age * male age 45 years or older * female age 55 years or older * patients with known hyperuricemia or with a history of gout * patients with an active peptic ulcer * patients with known coronary artery disease, cerebrovascular disease or peripheral arterial disease that has previously required percutaneous coronary intervention or surgical intervention * patients with known intolerance or allergy to niacin * patients consuming more than 10 alcoholic drinks per week * patients with a history of drug abuse * patients receiving any lipid modifying agent within 4 weeks of entry into the baseline period * patients participating in another clinical trial within 30 days of entry into the baseline period * patients considered to be non-compliant to study medication (\< 80% study medication) or diet during the placebo-baseline phase * patients for whom the investigator determines that the study would not be appropriate

Keywords: triglycerides cholesterol