TRIal For Efficacy of Capre on hyperTriglyceridemiA

NCT ID: NCT01455844

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CaPre 1.0g

Group Type: EXPERIMENTAL

CaPre (TM)

Intervention Type: DRUG

CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.

CaPre 2.0g

Group Type: EXPERIMENTAL

CaPre (TM)

Intervention Type: DRUG

CaPre™ 2.0g daily for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks

Interventions

CaPre (TM)

CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.

Intervention Type: DRUG

Placebo

2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks

Intervention Type: OTHER

CaPre (TM)

CaPre™ 2.0g daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JSS Medical Research Inc.

INDUSTRY

Sponsor Role: collaborator

Grace Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Genest, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Cardiology Division, MUHC

Locations

Cardiology Research

Edmonton, Alberta, Canada

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

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

Countries

Canada

Other Identifiers

PRT-API-NKPL66-CT-PII

Identifier Type: -

Identifier Source: org_study_id