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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519714
Other study ID # PNAI-MNA-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2007
Est. completion date November 2008

Study information

Verified date February 2020
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.
Placebo
Placebo

Locations

Country Name City State
Canada Institut de Cardiologie de Montreal Montreal Quebec

Sponsors (23)

Lead Sponsor Collaborator
Montreal Heart Institute Cambridge Cardiac Care Centre, Centre de médecine genique communautaire, Clinique des maladies lipidiques de Québec, Commonwealth Medical Clinic, Diabetes Research, Vancouver General Hosp, Dr.Kim W Tan, First Line Medical Ltd, Hotel Dieu Hospital, Institut de Recherches Cliniques de Montreal, Manna Research, Maritime Research Center, MSHJ Research Associates, Omnispec clinical research Inc, Queen Elizabeth II Health Sciences Centre, Recherche Invascor Inc, Rhodin Recherche Clinique, Royal Victoria Hospital, Canada, St Michael's Hospital Health Center, St Paul's Hospital Healthy Heart Clinical Trial, St. Jerome Medical Research Inc., The Allin Clinic, The Clinical Trials Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percent change in total serum Triglycerides from baseline to end of study 12 weeks
Secondary The percent change in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, high-density lipoprotein cholesterol , total apolipoprotein B , apolipoprotein A1 and TG/HDL-C ratio from baseline to end of study. One year
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