Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758303
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):
Cortria Corporation

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.

Layout table for study information
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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758303

Sponsors and Collaborators
Cortria Corporation
Layout table for investigator information
Principal Investigator: Jean C Tardif, M.D. Montreal Heart Center
Additional Information:
Layout table for additonal information
Responsible Party: Cortria Corporation Identifier: NCT00758303    
Other Study ID Numbers: Cortria-001
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: August 2013
Keywords provided by Cortria Corporation:
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipid Metabolism Disorders
Metabolic Diseases