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1 Clinical Trial Details (PDF Generation Date :- Sat, 14 Jul :24:10 GMT) CTRI Number Last Modified On 05/04/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/01/ [Registered on: 17/01/2014] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Placebo Controlled Trial Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medications A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When evolocumab is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) (Superseding Protocol Amendment 6, dt.20 Oct 2015) Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Sagar Patil Reginal Clinical Trial Manager Amgen Technology Pvt Ltd Phone Fax Designation Affiliation A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) Mumbai India psagar@amgen.com Details Contact Person (Public Query) Dr Veena Jaguste Phone Fax Dir Development Operations Amgen Technology Pvt. Ltd A Wing, Level 4, Dynasty Business Park A.K Road, Andheri (East) Mumbai India page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment > Amgen Inc. Type of Sponsor NIL List of Countries Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Colombia Czech Republic Democratic People's Republic of Korea Denmark Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Ireland Israel Italy Japan Latvia Lithuania Malaysia Mexico Netherlands New Zealand Norway Philippines Poland Portugal Source of Monetary or Material Support Primary Sponsor Details Amgen Technology Pvt Ltd A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) Mumbai India PIN : Other [Biotechnology Company] NIL page 2 / 8

3 Sites of Study Romania Russian Federation Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Turkey Ukraine United Kingdom United States of America of Principal Investigator Dr Bhagirath Solanki of Site Site Phone/Fax/ B. J. Medical College & Civil Hospital B. J. Medical College & Civil Hospital, Dept of Internal Medicine, Asarwa, Ahmedabad , Gujarat. Ahmadabad Dr Keyur Parikh Dr. Keyur Parikh Care Institute of Medical Sciences(CIMS) Opp. Panchamrut Bunglows, Near Shukan Mall, Off Science City Road, Sola, Ahmedabad , Gujarat, India Ahmadabad Dr Ramesh Babu Pothineni Dr. Ramesh Cardiac & Multispeciality Hospital Pvt. Ltd Dr. Ramesh Cardiac & Multispeciality Hospital Pvt. Ltd. Cardiology, Ring Road, near ITI College, Vijayawada Andhra Pradesh, India Krishna ANDHRA PRADESH Dr Vimal Mehta G.B. Pant Hospital G.B. Pant Hospital, Dept of Cardiology, J.L. Nehru Marg, New Delhi New Delhi DELHI Dr Vinod Khandait Government Medical College & Hospital Cardiology, Government Medical College & Hospital, Medical College Square, Hanuman Nagar, Nagpur Maharashtra, India Nagpur drbhagirath@yahoo.co.i n keyur.parikh@cims.me dr_rameshbabu_p@ya hoo.co.in drvimalmehta@yahoo.c o.in drkhandait@rediffmail.c om page 3 / 8

4 Dr Sudhanshu Kumar Dwivedi Dr Veerappa Kothiwale Dr Ajaykumar Mahajan Dr Sunita Aggarwal King Georges Medical University KLEs Dr. Prabhakar Kore Hospital and Medical Research Cente Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College Maulana Azad Medical College Cardiology, King Georges Medical University, Chowk, Lucknow , Uttar Pradesh, India Lucknow UTTAR PRADESH KLEs Dr. Prabhakar Kore Hospital and Medical Research Cente, Cardiology,Nehru Nagar, Belgaum ,Karnataka, India Belgaum KARNATAKA Cardiology, Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College,Road no 18, Sion Mumbai , Maharashtra Mumbai Maulana Azad Medical College, Medicine, 122, B.L. Taneja Block, Delhi Gate, Bahadur Shah Zafar Marg, New Delhi New Delhi DELHI Dr Vijay Chopra Medanta- The Medicity Medanta- The Medicity Cardiology, Rajiv Chowk, Gurgaon , Haryana, India Gurgaon HARYANA Dr Ravishankar Govinda Dr Abhijeet Joshi Mysore Medical College and Research Institute Niraramaya Hospital Pvt. Ltd Mysore Medical College and Research Institute, General Medicine, Irwin Road, Opposite K R Hospital, Mysore, Karnataka India Mysore KARNATAKA Niraramaya Hospital Pvt. Ltd, Behind Jaihind petrol pump, Next to Chinchwad (E) Post office, Chinchwad, Pune dr_skdwivedi@rediffmai l.com nov10kothiwale@yahoo.co.in draumahajan@gmail.co m drsunita.mamc@gmail. com VK.Chopra@Medanta.o rg airodyravishank@yaho o.co.in drabhijeetjoshi1000@g mail.com page 4 / 8

5 Details of Ethics Committee Dr Rahul Pai Dr Anil Jain Dr Sunil Tyagi Oyster and Pearl Hospital SAL Hospital and Medical Institute Seth L.G. Municipal General Hospital & AMC MET Medical College Pune Survey number , Ganeshkhind Road, Shivaji Nagar, Pune , Maharashtra, India. Pune SAL Hospital and Medical Institute,Drive in Road, Thaltej Opposite Doordarshan Tower,Ahmedabad , Gujarat Ahmadabad Dr Govind Kulkarni Shree Hospital Endocrinology, Shree Hospital Siddharth Mansion, Nagar Road Opposite Aga Khan Palace Pune, Maharashtra, , India Pune Dr Mahendra Parmar SSG Hospital & Baroda Medical College Dr Girish Rajadhyaksha Topiwala National Medical College & B.Y..L Nair Charitable Hospital pairahul73@gmail.com dranilrjain@yahoo.co.in Medicine, Seth L.G Municipal General tyagisunil1961@gmail.c Hospital & AMC MET om Medical College Maninagar, Ahmedabad Gujarat. Ahmadabad SSG Hospital & Baroda Medical College, Medicine, Vadodara , Gujarat Vadodara Topiwala National Medical College & B.Y..L Nair Charitable Hospital, Medicine, Dr. A.L Nair Road, Mumbai Mumbai drgdk2001@yahoo.co.u k mcparmar1961@gmail. com girishraj63@hotmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? AMC MET Ethics Committee - Dr. Sunil Tyagi Approved 23/11/2015 No Ethics Committee - SAL Approved 18/11/2015 No page 5 / 8

6 Hospital and Medical Institute - Dr. Anil Jain Ethics Committee of Care Institute of Medical Science - Dr. Keyur Parikh Ethics Committee of KLE University Dr. Veerappa Kothiwale Ethics Committee of Shree Hospital - Dr Govind Kulkarni Committee B.J.Medical College & Civil Hospital -Dr Solanki Committee Cardiac and Multispeciality Hospital Private Limited - Dr Ramesh Committee on Human Research - Dr Mahendra Parmar Approved 09/11/2015 No Approved 15/02/2016 No Approved 04/01/2016 No Approved 10/03/2016 No Approved 20/11/2015 No Approved 20/01/2016 No Committee, Department of Pharmacology, Government Medical College -Dr. Vinod Khandait Approved 02/01/2016 No Committee, King Georges Medical College - Dr. Sudanshu Kumar Dwivedi Committee, Lokmanya Tilak Municipal Medical College - Dr. Ajay Kumar Mahajan Committee, Maulana Azad Medical College - Dr VimalMehta Committee, Maulana Azad Medical College - Dr. Sunita Aggrawal Approved 05/06/2013 No Approved 24/11/2015 No Approved 21/01/2016 No Approved 21/01/2016 No Committee, Mysore Medical College & Research Institute and Associated Hospitals Dr Ravishankar Govinda Approved 04/01/2016 No Committee, Topiwala National Medical Approved 02/02/2016 No page 6 / 8

7 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria College & B.Y.L. Nair Charitable Hospital - Dr Girish Rajadhyaksha Medanta Institutional Ethics Committee - Dr Vijay Chopra Niramaya Hospital Ethics Committee - Dr. Abhijeet Joshi O&P Committee - Dr Rahul Pai Status Approved 17/02/2016 No Approved 07/12/2015 No Approved 21/02/2017 No Date Approved/Obtained 29/12/2015 Health Type Patients Condition Dyslipidemia Type Details Intervention Comparator Agent Age From Age To Gender Details Evolocumab (AMG 145) and Effective statin therapy Placebo and Effective statin therapy Year(s) Year(s) Both Inclusion Criteria Experimental: Arm 1 Evolocumab (AMG 145) will be administered at 1 of 2 regimens: Q2W (1 prefilled AI/Pen injection) or QM (3 prefilled AI/Pen injections or 1 Personal Injector injection) plus effective statin Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin for duration of up to approximately 5 years Placebo Comparator: Arm 2 Placebo will be administered at 1 of 2 regimens: Placebo SC Q2W (1 prefilled AI/Pen injection) or Placebo SC QM (3 prefilled AI/Pen injections or 1 Personal Injector injection) Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin for duration of up to approximately 5 years 1. Male or female? 40 to? 85 years of age {Note: For India the upper age will be limited to 80yrs as per DCGI approval letter} 2. History of clinically evident cardiovascular disease at high risk for a recurrent event 3. Fasting LDL-C? 70 mg/dl (? 1.8 mmol/l) ) or non-hdl-c? 100 mg/dl (> 2.6 mmol/l) 4. Fasting triglycerides? 400 mg/dl (4.5 mmol/l) Exclusion Criteria Details Exclusion Criteria 1. NYHA class III or IV, or last known left ventricular ejection fraction page 7 / 8

8 Powered by TCPDF ( PDF of Trial less than 30% 2. Uncontrolled hypertension 3. Uncontrolled or recurrent ventricular tachycardia 4. Untreated hyperthyroidism or hypothyroidism 5. Homozygous familial hypercholesterolemia 6. LDL or plasma apheresis 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 The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and hemorrhagic.) The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first Other secondary endpoints are: time to cardiovascular death time to death by any cause time to first myocardial infarction time to first stroke time to first coronary revascularization time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first Total Sample Size=27500 Sample Size from India= /04/ /02/2013 Years=5 Months=0 Days=0 Completed Completed Not applicable The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint The primary hypothesis is that additional LDL-C lowering with AMG 145 when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease. page 8 / 8