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

NCT00758303 | Completed Phase 2 DMC

• 1 other identifier: Cortria-001
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperlipidemia

Keywords

Triglycerides; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Low Dose TRIA-662

Drug: Low Dose TRIA-662

2

ACTIVE COMPARATOR

High Dose TRIA-662

Drug: High Dose TRIA-662

3

PLACEBO COMPARATOR

Matching Placebo for TRIA-662

Drug: Placebo for TRIA-662

Interventions

Low Dose TRIA-662 DRUG

One Capsule 3 times a day

Also known as: 1-MNA

1

High Dose TRIA-662 DRUG

3 Capsules 3 times daily

Also known as: 1-MNA

2

Placebo for TRIA-662 DRUG

Matching Placebo for TRIA-662 taken 3 times a day

Also known as: Placebo

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cortria Corporation: lead

Related Links

• Cortria Corporation

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jean C Tardif, M.D.

  Montreal Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 13, 2013

Record last verified: 2013-08