A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Summary

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 1-MNA or 90 mg 1-MNA 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. Additionally, blood samples will be drawn at randomisation and at clinic visits during the active treatment period for sparse sampling population pharmacokinetic assessments. All blood samples for lipid assessments and glucose measurements will be collected following a 12-hour fast. Safety and tolerability will be assessed throughout the trial through the evaluation of physical exams, ECGs, routine hematology and blood chemistry testing, and adverse events.

Conditions

• Hypertriglyceridemia

Interventions

DIETARY_SUPPLEMENT

1-Methylnicotinamide (1-MNA)

Following a 6-8-week placebo and dietary-controlled baseline period, 195 men and women will be randomized to receive placebo, 30 mg MNA or 90 mg MNA three times daily for twelve weeks.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• Commonwealth Medical Clinic

  collaborator UNKNOWN

• Institut de Recherches Cliniques de Montreal

  collaborator OTHER

• Clinique des maladies lipidiques de Québec

  collaborator UNKNOWN

• Centre de médecine genique communautaire

  collaborator UNKNOWN

• Omnispec clinical research Inc

  collaborator UNKNOWN

• Manna Research

  collaborator UNKNOWN

• St. Jerome Medical Research Inc.

  collaborator OTHER

• Royal Victoria Hospital, Canada

  collaborator OTHER

• Hotel Dieu Hospital

  collaborator OTHER

• St Michael's Hospital Health Center

  collaborator UNKNOWN

• Cambridge Cardiac Care Centre

  collaborator OTHER

• Maritime Research Center

  collaborator OTHER

• Rhodin Recherche Clinique

  collaborator UNKNOWN

• Queen Elizabeth II Health Sciences Centre

  collaborator OTHER

• First Line Medical Ltd

  collaborator UNKNOWN

• Diabetes Research, Vancouver General Hosp

  collaborator UNKNOWN

• The Allin Clinic

  collaborator OTHER

• St Paul's Hospital Healthy Heart Clinical Trial

  collaborator UNKNOWN

• The Clinical Trials Centre

  collaborator UNKNOWN

• Recherche Invascor Inc

  collaborator OTHER

• MSHJ Research Associates

  collaborator OTHER

• Dr.Kim W Tan

  collaborator UNKNOWN

• Montreal Heart Institute

  lead OTHER

Principal Investigators

• Jean-Claude Tardif, MD · Montreal Heart Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2008-10-31

Completion

2008-11-30

Countries

• Canada

Study Locations