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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Low Dose TRIA-662

High Dose TRIA-662

Placebo for TRIA-662

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Triglycerides, Cholesterol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Low Dose TRIA-662

High Dose TRIA-662

Matching Placebo for TRIA-662

Outcomes

Primary Outcome Measures

The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study

Secondary Outcome Measures

The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers

Full Information

NCT ID

NCT00758303

First Posted

September 23, 2008

Last Updated

August 29, 2013

Sponsor

Cortria Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00758303

Brief Title

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

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cortria Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

Keywords

Triglycerides, Cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Low Dose TRIA-662

Arm Title

Arm Type

Active Comparator

Arm Description

High Dose TRIA-662

Arm Title

Arm Type

Placebo Comparator

Arm Description

Matching Placebo for TRIA-662

Intervention Type

Drug

Intervention Name(s)

Low Dose TRIA-662

Other Intervention Name(s)

1-MNA

Intervention Description

One Capsule 3 times a day

Intervention Type

Drug

Intervention Name(s)

High Dose TRIA-662

Other Intervention Name(s)

1-MNA

Intervention Description

3 Capsules 3 times daily

Intervention Type

Drug

Intervention Name(s)

Placebo for TRIA-662

Other Intervention Name(s)

Placebo

Intervention Description

Matching Placebo for TRIA-662 taken 3 times a day

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean C Tardif, M.D.

Organizational Affiliation

Montreal Heart Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.cortria.com

Description

Cortria Corporation

Learn more about this trial

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

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