NCT00519714

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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2007-08-23
• Last updated: 2020-02-21

Locations

1 site across 1 country: Canada