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

This study has been completed.

Sponsors and Collaborators:	Montreal Heart Institute Montreal Heart Institute; Montreal, QC, H1T 1C8, Canada Commonwealth Medical Clinic; Mount Pearl, NL, A1N 2C3, Canada Institut de Recherches Cliniques de Montreal; Montreal, QC, H2W 1R7, Canada Clinique des maladies lipidiques de Québec; Quebec, QC, G1V 4M6, Canada Centre de médecine genique communautaire; Chicoutimi, QC, G7H 5H6, Canada Omnispec clinical research Inc;Mirabel, QC, J7J 2K8, Canada Manna Research; Toronto, ON, M9W 4L6, Canada St Jerome Medical Research Inc.; St-Jerome, QC, J7Z 5T3, Canada MUHC Royal Victoria Hospital; Montreal, QC, H3A 1A1, Canada Hotel Dieu Hospital St Michael's Hospital Health Center; Toronto, ON, M5C 2T2, Canada Cambridge Cardiac Care Centre; Cambridge, ON, N1R 6V6, Canada Maritime Research Center; Bathurst, NB, E2A 4X7, Canada Rhodin Recherche Clinique; Drummondville, QC, J2B 7T1, Canada Queen Health Sciences Centre;Halifax, NS, B3H 2Y9, Canada First Line Medical Ltd; St-John's, NL, A1E 2C2, Canada Diabetes Research, Vancouver General Hosp; Vancouver, BC, V5Z 1L8, Canada The Allin Clinic St Paul's Hospital Healthy Heart Clinical Trial; Vancouver, BC, V6Z 1Y6, Canada The Clinical Trials Centre; St-John's, NL, A1C 2H5, Canada Invascor Clinical Research; Longueuil, QC, J4N 1E1, Canada MSHJ Research Associates; Halifax, NS, B3K 5R3, Canada Dr.Kim W Tan; Ottawa, ON, K1C 1S6, Canada
Information provided by:	Montreal Heart Institute
ClinicalTrials.gov Identifier:	NCT00519714

Purpose

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.

Condition	Intervention	Phase
Hypertriglyceridemia	Dietary Supplement: 1-Methylnicotinamide (1-MNA) Dietary Supplement: Placebo	Phase II Phase III

MedlinePlus related topics: Dietary Supplements Triglycerides

Drug Information available for: Lipids BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:

The percent change in total serum Triglycerides from baseline to end of study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	195
Study Start Date:	September 2007
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator three placebo capsules PO three times daily.	Dietary Supplement: Placebo Placebo
2: Active Comparator 1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily	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.
3: Active Comparator 1-MNA 270 mg daily: three active treatment capsules PO three times daily.	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.

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 (ALT or AST greater than 1.5 ULN, bilirubin greater than 1.5 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 PCI 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: NCT00519714

Locations

Canada, Quebec
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

Montreal Heart Institute

Montreal Heart Institute; Montreal, QC, H1T 1C8, Canada

Commonwealth Medical Clinic; Mount Pearl, NL, A1N 2C3, Canada

Institut de Recherches Cliniques de Montreal; Montreal, QC, H2W 1R7, Canada

Clinique des maladies lipidiques de Québec; Quebec, QC, G1V 4M6, Canada

Centre de médecine genique communautaire; Chicoutimi, QC, G7H 5H6, Canada

Omnispec clinical research Inc;Mirabel, QC, J7J 2K8, Canada

Manna Research; Toronto, ON, M9W 4L6, Canada

St Jerome Medical Research Inc.; St-Jerome, QC, J7Z 5T3, Canada

MUHC Royal Victoria Hospital; Montreal, QC, H3A 1A1, Canada

Hotel Dieu Hospital

St Michael's Hospital Health Center; Toronto, ON, M5C 2T2, Canada

Cambridge Cardiac Care Centre; Cambridge, ON, N1R 6V6, Canada

Maritime Research Center; Bathurst, NB, E2A 4X7, Canada

Rhodin Recherche Clinique; Drummondville, QC, J2B 7T1, Canada

Queen Health Sciences Centre;Halifax, NS, B3H 2Y9, Canada

First Line Medical Ltd; St-John's, NL, A1E 2C2, Canada

Diabetes Research, Vancouver General Hosp; Vancouver, BC, V5Z 1L8, Canada

The Allin Clinic

St Paul's Hospital Healthy Heart Clinical Trial; Vancouver, BC, V6Z 1Y6, Canada

The Clinical Trials Centre; St-John's, NL, A1C 2H5, Canada

Invascor Clinical Research; Longueuil, QC, J4N 1E1, Canada

MSHJ Research Associates; Halifax, NS, B3K 5R3, Canada

Dr.Kim W Tan; Ottawa, ON, K1C 1S6, Canada

Investigators

Principal Investigator:

Jean-Claude Tardif, MD

Montreal Heart Institute

Responsible Party:	Montreal Heart Institute ( Jean-Claude Tardif/Researcher )
Study ID Numbers:	PNAI-MNA-001
Study First Received:	August 21, 2007
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00519714
Health Authority:	Canada: Health Canada