HypertriglyceridemiaPhase 2TRIFECTANCT01455844
TRIal For Efficacy of Capre on hyperTriglyceridemiA
A Phase 2 study testing CaPre (TM) in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 38 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- CaPre (TM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 38 sitesCanada
- Study dates
- Sep 2011to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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:
- Omega-3 fatty acids (including EPA and DHA)
- Phospholipids (mainly phosphatidylcholine)
- Astaxanthin
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Canada38 sites
Scisco Clinical Research
Cornwall, Ontario
Corunna Medical Resarch Centre
Corunna, Ontario
Source Unique Research Inc.
Dollard-des-Ormeaux, Quebec
Cardiology Research
Edmonton, Alberta
CLIN DE MED Grand-Mere
Grand-Mère, Quebec
Hamilton Health Sciences
Hamilton, Ontario
MD-Medical Professional Corporation
Hamilton, Ontario
Source Unique Research Inc.
Hawkesbury, Ontario
Study site
Kelowna, British Columbia
Bagot Street Medical Centre
Kingston, Ontario
KGK Synergize Inc.
London, Ontario
Milestone Research
London, Ontario
Robarts Research Institute
London, Ontario
SPARC, Siebens-Drake Research Institute
London, Ontario
S & G Clinical Research
Mississauga, Ontario
Diex Research Montreal Inc.
Montreal, Quebec
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
SKDA Research Inc.
Newmarket, Ontario
Study site
Niagara Falls, Ontario
Centre Medical Phoenix
Ottawa, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario
Medical Arts Health Research Group
Penticton, British Columbia
Dynamik Research Inc.
Pointe-Claire, Quebec
Kells Medical Research
Pointe-Claire, Quebec
Clinique des Maladies Lipidiques de Quebec Inc
Québec, Quebec
Clinique Médicale St-Louis
Québec, Quebec
Pro-Recherche Inc.
Saint Romuald, Quebec
Centre médical-des-carrières
Saint-Marc-des-Carrieres, Quebec
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
Sarnia Institute of Clinical Research
Sarnia, Ontario
Scarborough Cardiology Research
Scarborough Village, Ontario
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec
First Line Medical Services Ltd
St. John's, Newfoundland and Labrador
White Hills Medical Clinic
St. John's, Newfoundland and Labrador
Canadian Phase Onward
Toronto, Ontario
St Paul's Hospital
Vancouver, British Columbia
CookMed Research
Victoria, British Columbia
About this study
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
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- CaPre (TM), Placebo
- Keywords
- Hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaPre (TM)Drug
CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
PlaceboOther
2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks
CaPre (TM)Drug
CaPre™ 2.0g daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CaPre 1.0g | Experimental | Not described Receives: Drug: CaPre (TM) |
| CaPre 2.0g | Experimental | Not described Receives: Drug: CaPre (TM) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
Measured: 12 weeks
Secondary outcomes (1)
Absolute change in triglycerides between the baseline and the 12-week assessment visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
- Investigators
- Jacques Genest, MD, FRCP(C), Principal investigator, Cardiology Division, MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455844
- Sponsor's protocol ID
- PRT-API-NKPL66-CT-PII
- Acronym
- TRIFECTA
- Status last verified
- Aug 2014
- First submitted
- 18 Oct 2011
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01455844
- Acronym / sponsor ID
- TRIFECTA / PRT-API-NKPL66-CT-PII
- Conditions
- Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Grace Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CaPre 1.0g | Experimental | Drug: CaPre (TM) |
| CaPre 2.0g | Experimental | Drug: CaPre (TM) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaPre (TM)CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks. | Drug | CaPre 1.0g |
| Placebo2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks | Other | Placebo |
| CaPre (TM)CaPre™ 2.0g daily for 12 weeks | Drug | CaPre 2.0g |
Primary outcome
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.
Time frame: 12 weeks
1 secondary outcome
Absolute change in triglycerides between the baseline and the 12-week assessment visit.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Genest, MD, FRCP(C) principal investigator
Cardiology Division, MUHC
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CaPre (TM) in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 38 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (%) change in triglycerides between the baseline and the 12-week assessment visit. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.