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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Low Dose TRIA-662
* Drug: High Dose TRIA-662
* Drug: Placebo for TRIA-662


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Low Dose TRIA-662 | Drug: Low Dose TRIA-662<br>* One Capsule 3 times a day<br>* Other names: 1-MNA;|
| Active Comparator: 2<br>High Dose TRIA-662 | Drug: High Dose TRIA-662<br>* 3 Capsules 3 times daily<br>* Other names: 1-MNA;|
| Placebo Comparator: 3<br>Matching Placebo for TRIA-662 | Drug: Placebo for TRIA-662<br>* Matching Placebo for TRIA-662 taken 3 times a day<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study |  | Baseline to end of 12 weeks of active treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers |  | From baseline to the end of 12 weeks of active treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triglycerides, Cholesterol