Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia
A Randomized Open-label Dose-ranging, Multi-center Trial to Assess the Safety and Efficacy of NKPL66(CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia
1 other identifier
interventional
289
1 country
38
Brief Summary
To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma serum triglycerides over a four week period in patients with mild-to-high hypertriglyceridemia as compared to the standard of care alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJanuary 8, 2014
January 1, 2014
1.4 years
January 19, 2012
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in fasting blood circulating serum TGs
The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.
Between baseline and 4 weeks of treatment.
Secondary Outcomes (6)
Absolute change in fasting plasma TGs
Baseline, Week 4 and Week 8
Patients achieving target TG fasting plasma levels
Baseline
Change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Between baseline and 4 and 8 weeks of treatment
Change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Between baseline and 4 and 8 weeks of treatment
Calculated ratios
The percent change in fasting blood circulating serum TGs Between baseline and 4 and 8 weeks of treatment.
- +1 more secondary outcomes
Study Arms (5)
Group A
ACTIVE COMPARATOR0.5g total CaPre™ from baseline to week 4 and 1.0g total CaPre™ from week 4 to week 8
Group B
ACTIVE COMPARATOR1.0g total CaPre™ from baseline to week 4 and 2.0g total CaPre™ from week 4 to week
Group C
ACTIVE COMPARATOR2.0g total CaPre™ from baseline to week 4 and 4.0g total CaPre™ from week 4 to week 8
Group D
OTHERStandard of care
Group E
ACTIVE COMPARATOR4.0g total CaPre™ from baseline to week 8
Interventions
1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
Eligibility Criteria
You may qualify if:
- 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 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.
- 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
You may not qualify if:
- 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 (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;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grace Therapeutics Inc.lead
- JSS Medical Research Inc.collaborator
Study Sites (38)
Alberta Health Services Clinical Trials
Red Deer, Alberta, Canada
Unknown Facility
Abbotsford, British Columbia, Canada
Unknown Facility
Kelowna, British Columbia, Canada
BC Diabetes
Vancouver, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
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
Unknown Facility
Hamilton, Ontario, Canada
Entralogix Clinical Research
Kitchener, Ontario, Canada
Entralogix Clinical Research
Mississauga, Ontario, Canada
Malton Medical Research Group
Mississauga, Ontario, Canada
Unknown Facility
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
Related Publications (1)
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.
PMID: 40258408DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Dufour, M.D.
Institut de Recherches Cliniques de Montreal
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 24, 2012
Study Start
December 1, 2011
Primary Completion
May 1, 2013
Study Completion
September 1, 2013
Last Updated
January 8, 2014
Record last verified: 2014-01