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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cortria Corporation
ClinicalTrials.gov Identifier:
NCT00758303
First received: September 23, 2008
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Hyperlipidemia
Drug: Low Dose TRIA-662
Drug: High Dose TRIA-662
Drug: Placebo for TRIA-662
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cortria Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: From baseline to the end of 12 weeks of active treatment ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758303

Sponsors and Collaborators
Cortria Corporation
Investigators
Principal Investigator: Jean C Tardif, M.D. Montreal Heart Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cortria Corporation
ClinicalTrials.gov Identifier: NCT00758303     History of Changes
Other Study ID Numbers: Cortria-001
Study First Received: September 23, 2008
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cortria Corporation:
Triglycerides
Cholesterol

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014