A Study to Evaluate the Lipid Regulating Effects of TRIA-662

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cortria Corporation

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