Clinical Trial Details (PDF Generation Date :- Thu, 11 Apr 2019 03:55:14 GMT) CTRI Number Last Modified On 14/06/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/002653 [Registered on: 15/05/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial 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. 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) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) AMR-01-01-0019 version 1.0 dated 2 Aug 2011 NCT01492361 Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Sanjay Kabra Director Clinical Research Phone 912240957478 Fax 912240957499 Email Designation Affiliation PharmaNet Clinical Services Pvt. Ltd. Unit 1101, Level 11, Millenia Tower B 1 and 2 Murphy Road 560 008 skabra@pharmanet-i3.com Details Contact Person (Public Query) Sanjay Kabra Director Clinical Research PharmaNet Clinical Services Pvt. Ltd. Unit 1101, Level 11, Millenia Tower B 1 and 2 Murphy Road page 1 / 8
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study 560 008 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 Type of Sponsor Primary Sponsor Details Amarin Pharma Inc 1430 Route 206, Suite 200, Bedminster, NJ 07921, USA Pharmaceutical industry-global Pharmanet Clinical Services Pvt Ltd Unit 1101, Level 11, Millenia Tower B, 1 and 2 Murphy Road -Karnataka List of Countries Australia Canada Netherlands New Zealand Poland Romania Russian Federation South Africa Ukraine United States of America of Principal Investigator of Site Site Phone/Fax/Email Dr Hemant Thacker Bhatia Hospital G1 Block (Ground Floor, Tardeo Road, Mumbai-422 005 Maharashtra, Mumbai MAHARASHTRA Dr Sunil Sathe Cardiac Care & Counselling Center 04th Floor, Park Plaza, Opp Kamala Nehru Park, Pune 411004, Maharashtra, Pune MAHARASHTRA 919820073882 drhpt@hotmail.com 91-20-25663890 svscardcare@gmail.co m Dr Johny Joseph Caritas Hospital Clinical Research Division, Thellakom PO, Kottayam 686016, Kerala Kottayam KERALA 919447124948 drjohnyjoseph@gmail.c om Dr Jitendra Pal Singh Sawhney Dharmavira Head Centre Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, -110060 NEW DELHI South 919810059773 jpssawhney@yahoo.co m page 2 / 8
DELHI Dr A Sharda Diabetes Center Endocrinology Department, 640, 1st Main, 1st Stage, Indiranagar, 560038, Karnataka, Dr Atul Mathur Fortis Escorts Heart Institute Okhla Road, New Delhi 110025, South DELHI Dr Rajpal Abhaichand GKNM Hospital Nethaji Road, Pappanaickenpalayam, Coimbatore 641 037, Tamil Nadu, Coimbatore TAMIL NADU Dr Ravikumar Aluru Global Hospitals Lakdikapool, Hyderabad 500004, Andhra Pradesh, Hyderabad ANDHRA PRADESH Dr Hathur Basavanagowdappa Dr V A Kothiwale Dr Rajendra Kumar Premchand JSS Medical College Hospital KLE s Dr. Prabhakar Kore Hospital & MRC Krishna Institute of Medical Sciences Dr Viswanathan Mohan Madras Diabetes Research Foundation Ramanuja Road, Mysore- 570004, Karnataka, Mysore Nehru Nagar, Belgaum- 590010 Belgaum No 1-8-31/1, Minister Road, Begumpet, Hyderabad 500003, Andhra Pradesh Hyderabad ANDHRA PRADESH #4, Conran Smith Road, Gopalapuram, Chennai 600086, Tamil Nadu Chennai TAMIL NADU Dr Ramesh Babu Medwin Hospital Raghava Rathna Towers, Chirag Ali Lane, Nampally, Hyderabad 500 001, Andhra Pradesh, Hyderabad ANDHRA PRADESH Dr Mukesh Sarna Monilek Hospital and Research Center Department of Internal Medicine Sector 4, Jawahar Nagar, Jaipur 302004. Rajasthan, Jaipur RAJASTHAN 919448063156 sharda.a@gmail.com 919810187115 atul_mathur@hotmail.c om 919443272172 drrajpal@yahoo.com 919848024638 ravi27369@yahoo.com 91-821-2548368 hbgowda@gmail.com 919448119899 kothiwale@yahoo.co.in 919848029443 kumarpre@hotmail.com 91-44-43968888 drmohans@vsnl.net 919177000889 rameshbabubyrapaneni @yahoo.co.in 91-141-2652181 mukeshsarna@gmail.c om page 3 / 8
Details of Ethics Committee Dr Malipeddi Bhaskara Rao Dr Nitin Ghaisas Dr Jugal Bihari Gupta Dr Santhosh Mysore Jayadev Dr Arun Srinivas Dr Sunil Dwivedi Queen s NRI Hospital Shatabdi Super Speciality Hospital SR Kalla Memorial Gastro and General Hospital St. John s Medical College Hospital Vikram Hospital Private Limited Vikram Hospital Private Limited Gurudwara Lane, Seethammadhara, Visakhapatnam- 530013, Andhra Pradesh Visakhapatnam ANDHRA PRADESH Suyojit city center, Opp.Mahamarg Bus Stand, Mumbai Naka, Nasik 422 005, Maharashtra, Nashik MAHARASHTRA 78 Dhuleshwar Garden, Behind HSBC bank, Sardar Patel Marg C-Scheme, Jaipur, Rajasthan, -302001 Jaipur RAJASTHAN 3rd Floor, Dept of Cardiology, Sarjapur Road, - 560034, Karnataka, Vivekananda Road, Yadavagiri, Mysore, Karnataka, 570020 Mysore No 71/1, Millers Road, 560052, Karnataka Dr SS Ramesh Vivus Heart Centre Vivus House, No.8, Millers Tank Bund Road, -560052, Karnataka Dr Mohanan Purayil Westfort Hi-Tech Hospital P.B No-930, Punkunnam, Thrissur- 680002, Kerala, Thrissur KERALA 919000744766 bhaskarstudies@hotma il.com 91-253-6639001 nitin.ghaisas@gmail.co m 919829414680 drjbgupta@gmail.com 919880350278 cardioresearch@gmail. com 919845028387 cardiology@vhpl.com 919845132745 dwivediksunil@rediffma il.com 919845033682 ssramesh@vivushealth. net 919846076006 drmohanan@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee-Global Hospitals, Hyderabad; Dr. Uday Prashant Approved 26/03/2012 No page 4 / 8
Ethics Committee of Biniwale Clinic, Pune; Dr. Sunil Sathe Committee of JSS Medical College Hospital, Mysore; Dr. Hathur Basavanagowdappa Approved 27/02/2012 Yes Approved 03/04/2012 No Shatabdi Hospital Approved 08/03/2012 No Ethics Committee; Nasik; Dr. Nitin Ghaisas S.R. Kalla Memorial Ethical Committee For Human Research, Jaipur; Dr. Jugal Bihari Gupta Ethics Committee of KLE University, Belgaum; Dr. V. A. Kothiwale committee, Monilek Hospital and Research centre, Jaipur; Dr. Mukesk Kumar Sarna Ethics Committee, Sir Ganga Ram Hospital, New Delhi; Dr. Jitendra Pal Singh Sawhney Approved 13/03/2012 No Approved 15/03/2012 No Approved 05/04/2012 No Approved 09/08/2012 No Vikram Hospital Ethics Approved 29/03/2012 No Committee; Mysore; Dr. Arun Srinivas Committee, Medwin Hospital, Nampally, Hyderabad; Dr. Ramesh Babu Committee; G. Kuppuswamy Naidu Memorial Hospital, Tamil Nadu; Dr. Rajpal Abhaichand Approved 26/04/2012 No Approved 22/03/2012 No Institutional Ethical Review Board, St. John s Medical College and Hospital, ;Dr. Santhosh Mysore Jayadev Approved 05/05/2012 No Clinical Trial Ethics Committee, Bhatia Hospital, Mumbai; Dr. Hemant Thacker Independent Ethics Committee, Science for Health, ; Dr A. Sharda Approved 27/03/2012 No Approved 10/07/2012 Yes page 5 / 8
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria The Independent Ethics Committee, Fortis Escorts Heart Institute, New Dehli; Dr Atul Mathur Ethics Committee Caritas Hospital, Kottayam; Dr. Johny Joseph Central Ethics Committee, ; Dr. Sunil Dwivedi Committee of Madras Diabetes Research, Chennai; Dr. Viswanathan Mohan Ethics Committee Westfort Hi-Tech Hospital, Thrissur; Dr. Mohanan Purayil Institutional Review Board, Bhagwan Mahaveer Jain Heart Centre, ; Dr. Ramesh Committee of Krishna Institute of Medical Sciences; Dr. Rajendra Kumar Premchand Institute Ethics Committee, Queen s NRI Hospital, Vishakhapatnam; Dr. Malipeddi Bhaskara Rao Status Approved 04/08/2012 Yes Approved 16/10/2012 No Approved 11/10/2012 No Approved 11/12/2012 No Approved 05/09/2012 No Approved 29/01/2013 No Approved 02/11/2012 No Approved 12/09/2012 No Date Approved/Obtained 04/05/2012 Health Type Patients Condition Cardiovascular Diseases Type Details Intervention AMR101 Oral, 4g daily (2 capsules of 1g given twice daily plus statin therapy) Duration of Therapy: 18 Months Comparator Agent Placebo capsule Oral, 4 capsules daily (2 capsules given twice daily plus statin therapy) Duration of Therapy: 18 Months Age From Age To Gender 45.00 Year(s) 99.00 Year(s) Both Inclusion Criteria page 6 / 8
Details 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 Exclusion Criteria Details Exclusion Criteria 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 Method of Concealment Blinding/Masking Computer generated randomization Centralized 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 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. Total Sample Size=7990 Sample Size from =1000 30/05/2012 21/11/2011 Years=5 Months=0 Days=0 Open to Recruitment Open to Recruitment 4-6 years This is a multi-center, multi-national, prospective, randomized, double-blind, page 7 / 8
Powered by TCPDF (www.tcpdf.org) placebo controlled, parallel-group study. This is an event-driven trial: Approximately 7990 patients will be randomized at multiple research sites worldwide including 22 sites in, 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-up of 4 years. The study end date is determined to be when sufficient primary efficacy events have occurred. page 8 / 8