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

Last updated: August 29, 2013
Sponsor: Cortria Corporation
Overall Status: Completed

Phase

2/3

Condition

Dyslipidemia

Hypercholesterolemia

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT00758303
Cortria-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients at least 18 years of age at the time of informed consent (women ofchildbearing 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) asmeasured 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 (highervalue minus lower value)/higher value < 0.25)

  • Patients willing and able to sign an informed consent form and follow the protocol

Exclusion

Exclusion Criteria:

  • Patients who are pregnant or nursing

  • Patients with evidence of hepatic dysfunction [alanine aminotransferase (ALT) oraspartate 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 (serumcreatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during thebaseline phase

  • Patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l orHbA1C above 10%) as measured during the baseline phase

  • Patients with hypothyroidism that is not treated or not stable for at least 6 monthsprior to study entry

  • Patients with uncontrolled hypertension (systolic blood pressure above 160 mm Hgand/or diastolic blood pressure above 110 mm Hg)

  • Patients with systolic blood pressure above 140 mm Hg AND three or more of thefollowing 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 peripheralarterial disease that has previously required percutaneous coronary intervention orsurgical 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 baselineperiod

  • Patients participating in another clinical trial within 30 days of entry into thebaseline 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

Study Design

Total Participants: 211
Study Start date:
September 01, 2007
Estimated Completion Date:
December 31, 2008

Study Description

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.