A study to determine the effectiveness and safety of AMR101 in reducing the risk of cardiovascular events (e.g. stroke, heart attack, unstable angina) in patients with high triglyceride levels and who are on statin treatments.
Scientific Title of Study
A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients with Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)
Trial Acronym
REDUCE-IT
Secondary IDs if Any
Secondary ID
Identifier
AMR-01-01-0019 version 1.0 dated 2 Aug 2011
Protocol Number
NCT01492361
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Sanjay Kabra
Designation
Director – Clinical Research
Affiliation
PharmaNet Clinical Services Pvt. Ltd.
Address
Unit 1101, Level 11, Millenia Tower B
1 and 2 Murphy Road
Bangalore
KARNATAKA
Bangalore KARNATAKA 560 008 India
Phone
912240957478
Fax
912240957499
Email
skabra@pharmanet-i3.com
Details of Contact Person Public Query
Name
Sanjay Kabra
Designation
Director – Clinical Research
Affiliation
PharmaNet Clinical Services Pvt. Ltd.
Address
Unit 1101, Level 11, Millenia Tower B
1 and 2 Murphy Road
Bangalore
KARNATAKA
Bangalore KARNATAKA 560 008 India
Phone
912240957478
Fax
912240957499
Email
skabra@pharmanet-i3.com
Source of Monetary or Material Support
Amarin Pharma Inc.
1430 Route 206, Suite 200, Bedminster, NJ 07921, USA
Primary Sponsor
Name
Amarin Pharma Inc
Address
1430 Route 206, Suite 200, Bedminster, NJ 07921, USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Pharmanet Clinical Services Pvt Ltd
Unit 1101, Level 11, Millenia Tower B, 1 and 2 Murphy Road Bangalore-Karnataka
Countries of Recruitment
Australia Canada India Netherlands New Zealand Poland Romania Russian Federation Ukraine United States of America South Africa
• Men and non-pregnant or sterile women ages 45 and older
• Hypertriglyceridemia
• On statin therapy for at least four weeks
• Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease
ExclusionCriteria
Details
• Severe heart failure
• Any life-threatening disease other than Cardiovascular Disease
• Active severe liver disease
• Hemoglobin A1c 10.0%
• Poorly controlled hypertension
• Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
• Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
• Known hypersensitivity to fish oil products
• History of acute or chronic pancreatitis
• Patients are excluded if using the following medications:
o niacin 200 mg/day or fibrates;
o any omega-3 fatty acid medications;
o dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
o bile acid sequestrants
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina
4-6 years
Secondary Outcome
Outcome
TimePoints
Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc.
Total Sample Size="7990" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a multi-center, multi-national, prospective, randomized, double-blind, placebocontrolled,parallel-group study.This is an event-driven trial: Approximately 7990 patients will be randomized atmultiple research sites worldwide including 22 sites in India, over a planned period of 18 months. After randomization,patients will be treated with AMR101 4 g daily with statin, or Placebo with statin. The patients will be followed over 3.25-4.75 years with a planned median follow-upof 4 years. The study end date is determined to be when sufficient primary efficacyevents have occurred.