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

This study has been completed.
Sponsor:
Collaborators:
Commonwealth Medical Clinic
Institut de Recherches Cliniques de Montreal
Clinique des maladies lipidiques de Québec
Centre de médecine genique communautaire
Omnispec clinical research Inc
Manna Research
St Jerome Medical Research Inc.
Royal Victoria Hospital, Canada
Hotel Dieu Hospital
St Michael's Hospital Health Center
Cambridge Cardiac Care Centre
Maritime Research Center
Rhodin Recherche Clinique
Queen Health Sciences Centre
First Line Medical Ltd
Diabetes Research, Vancouver General Hosp
Allin Clinic
St Paul's Hospital Healthy Heart Clinical Trial
The Clinical Trials Centre
Invascor Clinical Research
MSHJ Research Associates
Dr.Kim W Tan
Information provided by:
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00519714
First received: August 21, 2007
Last updated: June 18, 2010
Last verified: January 2009
  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 2
Phase 3

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

Resource links provided by NLM:


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
Placebo Comparator: 1
three placebo capsules PO three times daily.
Dietary Supplement: Placebo
Placebo
Active Comparator: 2
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.
Other Name: 1-MNA
Active Comparator: 3
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.
Other Name: 1-MNA

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Jean-Claude Tardif/Researcher, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00519714     History of Changes
Other Study ID Numbers: PNAI-MNA-001
Study First Received: August 21, 2007
Last Updated: June 18, 2010
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 20, 2014