TRIal For Efficacy of Capre on hyperTriglyceridemiA (TRIFECTA)

August 21, 2014 updated by: Acasti Pharma Inc.

A Randomized, Placebo-controlled, Double-blind, Dose-ranging, Multi-centered Trial to Evaluate the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for 12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high hypertriglyceridemia as compared to a placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
387

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Cardiology Research
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Penticton, British Columbia, Canada
        • Medical Arts Health Research Group
      • Vancouver, British Columbia, Canada
        • St Paul's Hospital
      • Victoria, British Columbia, Canada
        • CookMed Research
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • First Line Medical Services Ltd
      • St. John's, Newfoundland and Labrador, Canada
        • White Hills Medical Clinic
    • Ontario
      • Cornwall, Ontario, Canada
        • Scisco Clinical Research
      • Corunna, Ontario, Canada
        • Corunna Medical Resarch Centre
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences
      • Hamilton, Ontario, Canada
        • MD-Medical Professional Corporation
      • Hawkesbury, Ontario, Canada
        • Source Unique Research Inc.
      • Kingston, Ontario, Canada
        • Bagot Street Medical Centre
      • London, Ontario, Canada
        • Robarts Research Institute
      • London, Ontario, Canada
        • Milestone Research
      • London, Ontario, Canada
        • KGK Synergize Inc.
      • London, Ontario, Canada
        • SPARC, Siebens-Drake Research Institute
      • Mississauga, Ontario, Canada
        • S & G Clinical Research
      • Newmarket, Ontario, Canada
        • SKDA Research Inc.
      • Niagara Falls, Ontario, Canada
      • Ottawa, Ontario, Canada
        • University of Ottawa Heart Institute
      • Ottawa, Ontario, Canada
        • Centre Medical Phoenix
      • Sarnia, Ontario, Canada
        • London Road Diagnostic Clinic and Medical Centre
      • Sarnia, Ontario, Canada
        • Sarnia Institute of Clinical Research
      • Scarborough, Ontario, Canada
        • Scarborough Cardiology Research
      • Toronto, Ontario, Canada
        • Canadian Phase Onward
    • Quebec
      • Dollard Des-Ormeaux, Quebec, Canada
        • Source Unique Research Inc.
      • Grand-Mere, Quebec, Canada
        • CLIN DE MED Grand-Mere
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Diex Research Montreal Inc.
      • Montreal, Quebec, Canada
        • Institut de recherches cliniques de Montréal (IRCM)
      • Pointe-Claire, Quebec, Canada
        • Dynamik Research Inc.
      • Pointe-Claire, Quebec, Canada
        • Kells Medical Research
      • Québec, Quebec, Canada
        • Clinique des Maladies Lipidiques de Quebec Inc
      • Québec, Quebec, Canada
        • Clinique Médicale St-Louis
      • Sherbrooke, Quebec, Canada
        • Diex Research Sherbrooke Inc.
      • St-Marc-des-carrières, Quebec, Canada
        • Centre médical-des-carrières
      • St-Romuald, Quebec, Canada
        • Pro-Recherche Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults aged 18 to 75 years.
  • Fasting plasma levels of TG ≥ 2.28 and <10 mmol/L (200 and 877 mg/dL) on two occasions within 2 weeks (screening and pre-randomization visits).
  • Patients who are currently not on pharmacotherapy for hyperlipidemia and according to the judgement of the physician and Canadian Guidelines for the Diagnosis and Treatment of Dyslipidemia initiation of drug therapy is not indicated for the duration of the study.
  • Patients currently treated with statins and according to the judgement of the physician and the Canadian Guidelines for the Diagnosis and Treatment of Dyslipidemia a change in their current drug regimen is not indicated for the duration of the study.
  • Patients treated with statin must be on stable dose for at least 6 weeks prior to screening.
  • Patients are willing follow the NCEP Step 1 Diet (see Appendix 4) for the duration of the study.

  • Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative serum pregnancy test and must be using an effective birth control method, defined as:

    1. continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or;
    2. use of an intra-uterine device or implantable contraceptive, or;
    3. use of double barrier methods of birth control
  • Patients are at least 80% compliant with the study medication during the placebo lead in phase.

Exclusion Criteria:

  • Any concomitant medication which in the opinion of the investigator would preclude the patient from successfully participating in the study.
  • Women who are pregnant or that are breast feeding.
  • Participation in another clinical trial within 30 days from initiation of the study.
  • Participants with a high risk for cardiovascular disease; (The definition of high-risk individuals will follow that of the 2009 Canadian Guidelines and include a) FRS >= 20% 10-year risk; b) All patients with uncontrolled diabetes (DCA guidelines) and c) Evidence of atherosclerosis -when this evidence was ascertained when clinically indicated);
  • Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg. In diabetic patients, systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 90 mmHg.
  • History of stroke, intermittent claudication or transient ischemic attack.
  • Known unstable (uncontrolled) cardiac disease , within the last 6 months.
  • Patient with a clinically significant abnormal ECG at screening.
  • Patients with uncontrolled diabetes mellitus, with HbA1c > 7.0%.
  • Known diagnosis of hypoglycemia.
  • Evidence of active renal disease indicated by a fasting estimated glomerular filtration rate (eGFR) of < 60 ml/min per 1.73 m2.
  • Increased plasma levels (>ULN) of amylase (as per respective lab upper limits) and / or lipase (>160 IU/L) or any indication of pancreatitis pancreatitis (increased alcohol consumption, gallstones).
  • History of pancreatitis.
  • Use of any lipid lowering medication other than statins or ezetimibe(e.g niacin, fibrates) and/or lipid lowering NHP within 6 weeks prior to the screening visit.
  • Intake of > 2 servings per week of fish or regimented use of fish oil/omega-3 supplements within 6 weeks prior to the screening visit.
  • Known HIV or Hepatitis B or C positive.
  • Patients with uncontrolled asthma as defined by the 2010 Consensus Summary of the Canadian Thoracic Society.

  • Known seafood allergy or allergy to any of the medicinal or non-medicinal ingredients of the study medication and placebo, including:

    1. Omega-3 fatty acids (including EPA and DHA)
    2. Phospholipids (mainly phosphatidylcholine)
    3. Astaxanthin
    4. Microcrystalline cellulose
  • Coagulopathy or on anticoagulants. Platelet aggregation inhibitors (such as aspirin or clopidogrel but not heparin) are permitted in the study; patients taking both aspirin and clopidogrel are not permitted in the study.
  • Unable or unwilling to comply with the protocol.
  • Patient reported weight was not stable for the past 6 months (within 3kg variation).
  • Consumption of more than 14 standard alcoholic drinks a week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Other: Placebo
2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks
EXPERIMENTAL: CaPre 1.0g
Drug: CaPre (TM)
CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
Drug: CaPre (TM)
CaPre™ 2.0g daily for 12 weeks
EXPERIMENTAL: CaPre 2.0g
Drug: CaPre (TM)
CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
Drug: CaPre (TM)
CaPre™ 2.0g daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute change in triglycerides between the baseline and the 12-week assessment visit.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acasti Pharma Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
JSS Medical Research Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacques Genest, MD, FRCP(C), Cardiology Division, MUHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRT-API-NKPL66-CT-PII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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