TRIal For Efficacy of Capre on hyperTriglyceridemiA
TRIFECTA
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
1 other identifier
interventional
387
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 22, 2014
August 1, 2014
2.8 years
October 18, 2011
August 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
12 weeks
Secondary Outcomes (1)
Absolute change in triglycerides between the baseline and the 12-week assessment visit.
12 weeks
Study Arms (3)
CaPre 1.0g
EXPERIMENTALCaPre 2.0g
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 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:
- 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
- Patients are at least 80% compliant with the study medication during the placebo lead in phase.
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 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grace Therapeutics Inc.lead
- JSS Medical Research Inc.collaborator
Study Sites (38)
Cardiology Research
Edmonton, Alberta, Canada
Unknown Facility
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
First Line Medical Services Ltd
St. John's, Newfoundland and Labrador, Canada
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Scisco Clinical Research
Cornwall, Ontario, Canada
Corunna Medical Resarch Centre
Corunna, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
MD-Medical Professional Corporation
Hamilton, Ontario, Canada
Source Unique Research Inc.
Hawkesbury, Ontario, Canada
Bagot Street Medical Centre
Kingston, Ontario, Canada
KGK Synergize Inc.
London, Ontario, Canada
Milestone Research
London, Ontario, Canada
Robarts Research Institute
London, Ontario, Canada
SPARC, Siebens-Drake Research Institute
London, Ontario, Canada
S & G Clinical Research
Mississauga, Ontario, Canada
SKDA Research Inc.
Newmarket, Ontario, Canada
Unknown Facility
Niagara Falls, Ontario, Canada
Centre Medical Phoenix
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
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 Village, Ontario, Canada
Canadian Phase Onward
Toronto, Ontario, Canada
Source Unique Research Inc.
Dollard-des-Ormeaux, Quebec, Canada
CLIN DE MED Grand-Mere
Grand-Mère, 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
Dynamik Research Inc.
Pointe-Claire, Quebec, Canada
Kells Medical Research
Pointe-Claire, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc
Québec, Quebec, Canada
Clinique Médicale St-Louis
Québec, Quebec, Canada
Pro-Recherche Inc.
Saint Romuald, Quebec, Canada
Centre médical-des-carrières
Saint-Marc-des-Carrieres, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Genest, MD, FRCP(C)
Cardiology Division, MUHC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
August 22, 2014
Record last verified: 2014-08