Clinical trial NCT01455844: TRIal For Efficacy of Capre on hyperTriglyceridemiA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: Hypertriglyceridemia
Lead sponsor: Grace Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
First posted: 2011-10-20
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
timeFrame: 12 weeks
Secondary outcomes:
measure: Absolute change in triglycerides between the baseline and the 12-week assessment visit.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cardiology Research
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: CookMed Research
state: British Columbia
city: St. John's
country: Canada
facility: First Line Medical Services Ltd
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: White Hills Medical Clinic
state: Newfoundland and Labrador
city: Cornwall
country: Canada
facility: Scisco Clinical Research
state: Ontario
city: Corunna
country: Canada
facility: Corunna Medical Resarch Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: MD-Medical Professional Corporation
state: Ontario
city: Hawkesbury
country: Canada
facility: Source Unique Research Inc.
state: Ontario
city: Kingston
country: Canada
facility: Bagot Street Medical Centre
state: Ontario
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: London
country: Canada
facility: Robarts Research Institute
state: Ontario
city: London
country: Canada
facility: SPARC, Siebens-Drake Research Institute
state: Ontario
city: Mississauga
country: Canada
facility: S & G Clinical Research
state: Ontario
city: Newmarket
country: Canada
facility: SKDA Research Inc.
state: Ontario
city: Niagara Falls
country: Canada
state: Ontario
city: Ottawa
country: Canada
facility: Centre Medical Phoenix
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Sarnia
country: Canada
facility: Sarnia Institute of Clinical Research
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Cardiology Research
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward
state: Ontario
city: Dollard Des-Ormeaux
country: Canada
facility: Source Unique Research Inc.
state: Quebec
city: Grand-Mere
country: Canada
facility: CLIN DE MED Grand-Mere
state: Quebec
city: Montreal
country: Canada
facility: Diex Research Montreal Inc.
state: Quebec
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal (IRCM)
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Pointe-Claire
country: Canada
facility: Dynamik Research Inc.
state: Quebec
city: Pointe-Claire
country: Canada
facility: Kells Medical Research
state: Quebec
city: Québec
country: Canada
facility: Clinique des Maladies Lipidiques de Quebec Inc
state: Quebec
city: Québec
country: Canada
facility: Clinique Médicale St-Louis
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: St-Marc-des-carrières
country: Canada
facility: Centre médical-des-carrières
state: Quebec
city: St-Romuald
country: Canada
facility: Pro-Recherche Inc.
state: Quebec
Study officials:
affiliation: Cardiology Division, MUHC
name: Jacques Genest, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: