Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia
NCT ID: NCT01516151
Last Updated: 2014-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2011-12-31
2013-09-30
Brief Summary
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Detailed Description
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As the prevalence of cardiometabolic disorders progressively increase over the years, it is expected that there will be an augmentation in the necessity for new anti-dyslipidemic medications that can most importantly be added in combination to other treatments. Current treatment methods address a specific target indication, but do not offer complete management of dyslipidemia.
We are now left with the option to either inadequately treat patients suffering from cardiovascular and metabolic disorders or, to prescribe combination treatments hoping to address the risk factors while mitigating their known side effects. A treatment gap exists since there is no medication that increases HDL-cholesterol and reduces triglycerides while reducing LDL-cholesterol without side effects.
At present there is a need to assess the effectiveness of CaPre™ in reducing triglycerides in patients with high hypertriglyceridemia. The current study will address these issues and will generate the evidence that will be required to determine whether this product could be effectively used in the clinical management of this patient population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
0.5g total CaPre™ from baseline to week 4 and 1.0g total CaPre™ from week 4 to week 8
CaPre™
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
CaPre™
1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
CaPre™
2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
CaPre™
4 capsules of 1 g total per day for 8 weeks.
Group B
1.0g total CaPre™ from baseline to week 4 and 2.0g total CaPre™ from week 4 to week
CaPre™
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
CaPre™
1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
CaPre™
2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
CaPre™
4 capsules of 1 g total per day for 8 weeks.
Group C
2.0g total CaPre™ from baseline to week 4 and 4.0g total CaPre™ from week 4 to week 8
CaPre™
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
CaPre™
1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
CaPre™
2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
CaPre™
4 capsules of 1 g total per day for 8 weeks.
Group D
Standard of care
Lipid Lowering Medication
Patient will be treated as per the Standard of care.
Group E
4.0g total CaPre™ from baseline to week 8
CaPre™
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
CaPre™
1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
CaPre™
2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
CaPre™
4 capsules of 1 g total per day for 8 weeks.
Interventions
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CaPre™
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
CaPre™
1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
CaPre™
2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
Lipid Lowering Medication
Patient will be treated as per the Standard of care.
CaPre™
4 capsules of 1 g total per day for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Fasting plasma levels of TG \> 2.28 and \< 10 mmol/L (200 and 877 mg/dL) on two occasions within 2 weeks (screening and baseline/part 1 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.
OR
* 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 to 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:
* continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or;
* use of an intra-uterine device or implantable contraceptive, or;
* use of double barrier methods of birth control
Exclusion Criteria
* 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 (increased alcohol consumption, gallstones);
* History of pancreatitis;
* Use of any lipid lowering medication other than statins (e.g niacin, fibrates or ezetimibe) 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;
* Intake of fortified foods containing plant sterols within 6 weeks prior to the screening visit;
* Known HIV or Hepatitis B or C positive;
* Patients with osteoporosis and hormone sensitive conditions;
* 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, including:
* Omega-3 fatty acids (including EPA and DHA)
* Phospholipids (mainly phosphatidylcholine)
* Astaxanthin
* Bovine gelatin
* 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 must be stable for the past 6 months (within 3kg variation);
* Consumption of more than 14 standard alcoholic drinks a week.
18 Years
75 Years
ALL
No
Sponsors
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JSS Medical Research Inc.
INDUSTRY
Grace Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Dufour, M.D.
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherches Cliniques de Montreal
Locations
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Alberta Health Services Clinical Trials
Red Deer, Alberta, Canada
Abbotsford, British Columbia, Canada
Kelowna, British Columbia, Canada
BC Diabetes
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Dieppe, New Brunswick, Canada
Entralogix Clinical Research
Aurora, Ontario, Canada
Entralogix Clinical Research
Brampton, Ontario, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada
Thamesview Ctr of Family Med
Chatam, Ontario, Canada
Moran Medical Centre
Colingwood, Ontario, Canada
C & L Research
Fort Erie, Ontario, Canada
G.S. Cardiac Lab Medicine Professional Corp
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Entralogix Clinical Research
Kitchener, Ontario, Canada
Entralogix Clinical Research
Mississauga, Ontario, Canada
Malton Medical Research Group
Mississauga, Ontario, Canada
Niagara Falls, Ontario, Canada
Entralogix Clinical Research
North York, Ontario, Canada
Taunton Health Centre
Oshawa, Ontario, Canada
Steeple Hill Medical centre
Pickering, Ontario, Canada
Entralogix Clinical Research
Toronto, Ontario, Canada
Eric Silver Medicine Professional Corporation
Toronto, Ontario, Canada
Clinique Médicale des Trois Lacs
Vaudreuil Dorion, Ontario, Canada
Clinique Medicale Valcartier
Courcelette, Quebec, Canada
Clinique Reseau le Trait d'Union
Delson, Quebec, Canada
Clinique Medicale Mistassini
Dolbeau-Mistassini, Quebec, Canada
Clinique medicale
Grand-Mère, Quebec, Canada
GMF Grand Mere
Grand-Mère, Quebec, Canada
CRM Lanaudiere
Joliette, Quebec, Canada
Applied Medical Information Research AMIR
Montreal, Quebec, Canada
Centre de recherche A&E
Québec, Quebec, Canada
Clinique des maladies lipidiques de Quebec Inc.
Québec, Quebec, Canada
Clinique Services Sante Rosemere
Rosemère, Quebec, Canada
Csss de St-Jerome
Saint-Jérôme, Quebec, Canada
CSSS Vallee De L'Or
Val-d'Or, Quebec, Canada
Applied Medical Information Research (AMIR)
Westmount, Quebec, Canada
Countries
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References
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Kim KS, Belley-Cote EP, Walsh M, Wang A, Balasubramanian K, Treleaven N, Garg AX, Guyatt G, Whitlock RP. Left atrial appendage occlusion study III-Kidney substudy. Am Heart J. 2025 Oct;288:90-100. doi: 10.1016/j.ahj.2025.04.018. Epub 2025 Apr 19.
Other Identifiers
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PRT-API-NKPL66-CT-PIIB
Identifier Type: -
Identifier Source: org_study_id
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