HypertriglyceridemiaPhase 2/3NCT00519714
A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)
A Phase 2/3 study testing 1-Methylnicotinamide (1-MNA) in people with Hypertriglyceridemia, run by Montreal Heart Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- 1-Methylnicotinamide (1-MNA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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)
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
- Being tested
- 1-Methylnicotinamide (1-MNA), Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Methylnicotinamide (1-MNA)Dietary supplement
Also called 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.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | three placebo capsules PO three times daily. Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | 1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily Receives: Dietary Supplement: 1-Methylnicotinamide (1-MNA) |
| 3 | Active comparator | 1-MNA 270 mg daily: three active treatment capsules PO three times daily. Receives: Dietary Supplement: 1-Methylnicotinamide (1-MNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in total serum Triglycerides from baseline to end of study
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- 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 Elizabeth II Health Sciences Centre, First Line Medical Ltd, Diabetes Research, Vancouver General Hosp, The Allin Clinic, St Paul's Hospital Healthy Heart Clinical Trial, The Clinical Trials Centre, Recherche Invascor Inc, MSHJ Research Associates, Dr.Kim W Tan
- Investigators
- Jean-Claude Tardif, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519714
- Sponsor's protocol ID
- PNAI-MNA-001
- Status last verified
- Feb 2020
- First submitted
- 21 Aug 2007
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)
- ClinicalTrials.gov ID
- NCT00519714
- Acronym / sponsor ID
- PNAI-MNA-001
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- 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 Elizabeth II Health Sciences Centre, First Line Medical Ltd, Diabetes Research, Vancouver General Hosp, The Allin Clinic, St Paul's Hospital Healthy Heart Clinical Trial, The Clinical Trials Centre, Recherche Invascor Inc, MSHJ Research Associates, Dr.Kim W Tan
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Placebothree placebo capsules PO three times daily. |
| 2 | Active comparator | Dietary Supplement: 1-Methylnicotinamide (1-MNA)1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily |
| 3 | Active comparator | Dietary Supplement: 1-Methylnicotinamide (1-MNA)1-MNA 270 mg daily: three active treatment capsules PO three times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Methylnicotinamide (1-MNA)Also: 1-MNAFollowing 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 | 2, 3 |
| PlaceboPlacebo | Dietary supplement | 1 |
Primary outcome
The percent change in total serum Triglycerides from baseline to end of study
Time frame: 12 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude Tardif, MD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1-Methylnicotinamide (1-MNA) in people with Hypertriglyceridemia, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change in total serum Triglycerides from baseline to end of study (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.