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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Drug: Low Dose TRIA-662; Drug: High Dose TRIA-662; Drug: Placebo for TRIA-662	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	211 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662
Study Start Date :	September 2007
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; Low Dose TRIA-662	Drug: Low Dose TRIA-662; One Capsule 3 times a day; Other Name: 1-MNA
Active Comparator: 2; High Dose TRIA-662	Drug: High Dose TRIA-662; 3 Capsules 3 times daily; Other Name: 1-MNA
Placebo Comparator: 3; Matching Placebo for TRIA-662	Drug: Placebo for TRIA-662; Matching Placebo for TRIA-662 taken 3 times a day; Other Name: Placebo

Outcome Measures

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Primary Outcome Measures :

1. The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study [ Time Frame: Baseline to end of 12 weeks of active treatment ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Sponsors and Collaborators

Cortria Corporation

Investigators

Principal Investigator:	Jean C Tardif, M.D.	Montreal Heart Center

More Information

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Additional Information:

Cortria Corporation 

Responsible Party:	Cortria Corporation
ClinicalTrials.gov Identifier:	NCT00758303 History of Changes
Other Study ID Numbers:	Cortria-001
First Posted:	September 25, 2008
Last Update Posted:	September 13, 2013
Last Verified:	August 2013

Keywords provided by Cortria Corporation:

Triglycerides; Cholesterol

Additional relevant MeSH terms:

Hyperlipidemias; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases