TRIal For Efficacy of Capre on hyperTriglyceridemiA

Hypertriglyceridemia Clinical Trial

— TRIFECTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455844
• Other study ID #: PRT-API-NKPL66-CT-PII
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2011
• Last updated: August 21, 2014
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Acasti Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Canadian Shields Ethics Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• CaPre (TM)
CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.

Other:
• Placebo
2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks

Drug:
• CaPre (TM)
CaPre™ 2.0g daily for 12 weeks

Locations

Country	Name	City	State
Canada	Scisco Clinical Research	Cornwall	Ontario
Canada	Corunna Medical Resarch Centre	Corunna	Ontario
Canada	Source Unique Research Inc.	Dollard Des-Ormeaux	Quebec
Canada	Cardiology Research	Edmonton	Alberta
Canada	CLIN DE MED Grand-Mere	Grand-Mere	Quebec
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	Diex Research Montreal Inc.	Montreal	Quebec
Canada	Institut de recherches cliniques de Montréal (IRCM)	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	SKDA Research Inc.	Newmarket	Ontario
Canada	Centre Medical Phoenix	Ottawa	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Medical Arts Health Research Group	Penticton	British Columbia
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	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	Scarborough Cardiology Research	Scarborough	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Centre médical-des-carrières	St-Marc-des-carrières	Quebec
Canada	Pro-Recherche Inc.	St-Romuald	Quebec
Canada	First Line Medical Services Ltd	St. John's	Newfoundland and Labrador
Canada	White Hills Medical Clinic	St. John's	Newfoundland and Labrador
Canada	Canadian Phase Onward	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	CookMed Research	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Acasti Pharma Inc.	JSS Medical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent (%) change in triglycerides between the baseline and the 12-week assessment visit.		12 weeks	No
Secondary	Absolute change in triglycerides between the baseline and the 12-week assessment visit.		12 weeks	No