TRIal For Efficacy of Capre on hyperTriglyceridemiA (TRIFECTA)

This study has been completed.
Sponsor:
Collaborator:
JSS Medical Research Inc.
Information provided by (Responsible Party):
Acasti Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01455844
First received: October 18, 2011
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
Drug: CaPre (TM)
Other: Placebo
Phase 2

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, 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

Resource links provided by NLM:


Further study details as provided by Acasti Pharma Inc.:

Primary Outcome Measures:
  • Percent (%) change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 387
Study Start Date: September 2011
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CaPre 1.0g Drug: CaPre (TM)
CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
Experimental: CaPre 2.0g Drug: CaPre (TM)
CaPre™ 2.0g daily for 12 weeks
Placebo Comparator: Placebo Other: Placebo
2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01455844

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

No publications provided

Responsible Party: Acasti Pharma Inc.
ClinicalTrials.gov Identifier: NCT01455844     History of Changes
Other Study ID Numbers: PRT-API-NKPL66-CT-PII
Study First Received: October 18, 2011
Last Updated: August 21, 2014
Health Authority: Canada: Health Canada
Canada: Canadian Shields Ethics Review Board

Keywords provided by Acasti Pharma Inc.:
Hypertriglyceridemia

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

ClinicalTrials.gov processed this record on September 18, 2014