Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

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
See also
  Status Clinical Trial Phase
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT02250105 - Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia Phase 2
Completed NCT02859129 - Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) Phase 1
Completed NCT01455844 - TRIal For Efficacy of Capre on hyperTriglyceridemiA Phase 2
Completed NCT01437930 - Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients N/A
Completed NCT01010399 - Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects Phase 4
Completed NCT00959842 - Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia Phase 1/Phase 2
Recruiting NCT00186537 - Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. N/A
Completed NCT00246402 - Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV N/A
Completed NCT06020950 - Chia Seeds Consumption in Hypertriglyceridemia N/A
Completed NCT02354976 - A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Phase 2
Completed NCT04966494 - Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women N/A
Completed NCT04630366 - A Phase 1, First Time in Humans Study of NST-1024 Phase 1
Completed NCT04650152 - Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Completed NCT03693131 - Efficacy of MND-2119 in Participants With Hypertriglyceridemia Phase 3
Completed NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Phase 2/Phase 3
Completed NCT04756180 - An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia. Phase 3
Completed NCT01968720 - Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia Phase 2
Completed NCT01462877 - A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic Phase 4
Completed NCT01211847 - Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia Phase 2