Clinical trial NCT00758303: A Study to Evaluate the Lipid Regulating Effects of TRIA-662
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Keywords: Triglycerides
Cholesterol
Lead sponsor: Cortria Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study
timeFrame: Baseline to end of 12 weeks of active treatment
Secondary outcomes:
measure: The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers
timeFrame: From baseline to the end of 12 weeks of active treatment
Other outcomes:
Locations:
Study officials:
affiliation: Montreal Heart Center
name: Jean C Tardif, M.D.
role: PRINCIPAL_INVESTIGATOR
References: