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

NCT ID: NCT00519714

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

three placebo capsules PO three times daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2

1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily

Group Type: ACTIVE_COMPARATOR

1-Methylnicotinamide (1-MNA)

Intervention Type: DIETARY_SUPPLEMENT

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

1-MNA 270 mg daily: three active treatment capsules PO three times daily.

Group Type: ACTIVE_COMPARATOR

1-Methylnicotinamide (1-MNA)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

1-MNA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commonwealth Medical Clinic

UNKNOWN

Sponsor Role: collaborator

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: collaborator

Clinique des maladies lipidiques de Québec

UNKNOWN

Sponsor Role: collaborator

Centre de médecine genique communautaire

UNKNOWN

Sponsor Role: collaborator

Omnispec clinical research Inc

UNKNOWN

Sponsor Role: collaborator

Manna Research

UNKNOWN

Sponsor Role: collaborator

St. Jerome Medical Research Inc.

OTHER

Sponsor Role: collaborator

Royal Victoria Hospital, Canada

OTHER

Sponsor Role: collaborator

Hotel Dieu Hospital

OTHER

Sponsor Role: collaborator

St Michael's Hospital Health Center

UNKNOWN

Sponsor Role: collaborator

Cambridge Cardiac Care Centre

OTHER

Sponsor Role: collaborator

Maritime Research Center

OTHER

Sponsor Role: collaborator

Rhodin Recherche Clinique

UNKNOWN

Sponsor Role: collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role: collaborator

First Line Medical Ltd

UNKNOWN

Sponsor Role: collaborator

Diabetes Research, Vancouver General Hosp

UNKNOWN

Sponsor Role: collaborator

The Allin Clinic

OTHER

Sponsor Role: collaborator

St Paul's Hospital Healthy Heart Clinical Trial

UNKNOWN

Sponsor Role: collaborator

The Clinical Trials Centre

UNKNOWN

Sponsor Role: collaborator

Recherche Invascor Inc

OTHER

Sponsor Role: collaborator

MSHJ Research Associates

OTHER

Sponsor Role: collaborator

Dr.Kim W Tan

UNKNOWN

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Montreal Heart Institute

Principal Investigators

Jean-Claude Tardif, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

PNAI-MNA-001

Identifier Type: -

Identifier Source: org_study_id