TRIal For Efficacy of Capre on hyperTriglyceridemiA (TRIFECTA)

This study is currently recruiting participants.
Verified October 2013 by Acasti Pharma Inc.
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: October 22, 2013
Last verified: October 2013

October 18, 2011
October 22, 2013
September 2011
June 2014   (final data collection date for primary outcome measure)
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01455844 on ClinicalTrials.gov Archive Site
Absolute change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TRIal For Efficacy of Capre on hyperTriglyceridemiA
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: CaPre (TM)
    CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
  • Other: Placebo
    2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks
  • Drug: CaPre (TM)
    CaPre™ 2.0g daily for 12 weeks
  • Experimental: CaPre 1.0g
    Intervention: Drug: CaPre (TM)
  • Experimental: CaPre 2.0g
    Intervention: Drug: CaPre (TM)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
429
Not Provided
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Francois Le Barbenchon, BSc. 514-934-6116 ext 231 fbarbenchon@jssresearch.com
Contact: Stella Boukas 514-934-6116 ext 229 sboukas@jssresearch.com
Canada
 
NCT01455844
PRT-API-NKPL66-CT-PII
No
Acasti Pharma Inc.
Acasti Pharma Inc.
JSS Medical Research Inc.
Principal Investigator: Jacques Genest, MD, FRCP(C) Cardiology Division, MUHC
Acasti Pharma Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP