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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 12:59:30 GMT) CTRI Number CTRI/2009/091/000201 [Registered on: 27/07/2009] - Last Modified On 24/07/2014 Post Graduate Thesis Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation Scientific Title of A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Study Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation Secondary IDs if Any Secondary ID Identifier EUDRACT: 2006-004595-13 EudraCT BAY59-7939/11630 DCGI NCT00403767 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ashish Gawde Query) Designation Country Medical Director India Affiliation Address Bayer Pharmaceuticals Private Limited Hiranandani Estate Thane MAHARASHTRA 400607 India Phone 02225311201 Fax 02225455007 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ashish Gawde Designation Country Medical Director India Affiliation Address Bayer Pharmaceuticals Private Limited Hiranandani Estate Thane MAHARASHTRA 400607 India page 1 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 02225311201 Fax 02225455007 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Bayer HealthCare AG, D-S1368 Leverkusen, Germany Primary Sponsor Primary Sponsor Details Name Bayer HealthCare AG Address Bayer HealthCare AG, D-S1368 Leverkusen, Germany Edit || Delete Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr. Abraham Oomman Apollo Hospital Tondiarpet, 044 25911111 No.645/646, T.H. 044 25911111 Road,Chennai ? drabrahamoomman@g 600081-600081 mail.com Chennai TAMIL NADU Dr Sharad Jain Apollo Hospitals Plot 1 A, Bhat Plot 1A, +91-79-66701876 International Ltd ,Bhat G.I.D.C Estate,- +91-79-66701876 382428 Ahmadabad GUJARAT Dr. A. Madhavan Apollo Speciality Lake View Road,K.K. 0452-2581157 Hospitals Nagar-625020 0452-2581157 Madurai Sangeeth2104@yahoo. TAMIL NADU co.in Dr. Darshan Bankers Heart Institute Near Tagorenagar, 0265-2324004 Navinchandra Banekr Opposite Suryakiran 0265-2327401 Complex,, Old Padra toralbankersheth@yaho Road- 390015 o.co.in Vadodara GUJARAT Dr. Hemant Thacker Bhatia hospital Tardeo,G- 1 +91-22-66660046 Block-400007 +91-22-66660046 Mumbai MAHARASHTRA Dr. Satej Janorkar Deenanath Mangeshkar Erandwane,Pune-4110 020 40151901 Hospital and Research 04 020 25420104 Centre Pune [email protected] MAHARASHTRA m Dr V.K. Chopra Escorts Heart Institute Okhla Road,-110025 011-26825000 & Research Center New Delhi 011-26825112 DELHI vijaykumarchopra@hot mail.com Dr Atul Abhyankar F -10 Sheron Plaza Opp. Ambika Niketan 0261-2254888 ,Bus Stop, Next to 0261-3072879 Athwalines [email protected] Road-395007 Surat page 2 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in GUJARAT Dr P.R Vydianathan G. Kuppuswamy Naidu P.B. No. 6327,Pappana 0422-2213501 Memorial Hospital ickenpalayam-641037 040-23204053 Coimbatore [email protected] TAMIL NADU Dr.V. Surya Prakasa Global Hospital 1070/1 to 4 ,Lakdi ka 040-23233166 Rao pool-500004 040-23233166 Hyderabad drsreenivasmurthy@gm ANDHRA PRADESH ail.com Dr Basavana JSS Medical College Ramanuja 0821-2421218 Gowdappa and Hospital Road,-570004 0821-2548368 Mysore [email protected] KARNATAKA Dr. V. Rajasekhar Kamineni Wockhardt No 4 - 1- 1227,King Koti 09247795073 Hospitals Road, ,Abids-50001 +91-40-66924222 Hyderabad ANDHRA PRADESH Dr. Milind Gadkari King Edward Memorial 4th Floor, T.D.H 020-66202260 Hospital Building,Rasta 020-66202260 Peth-411011 [email protected] Pune .in MAHARASHTRA Dr. Kulasekaran Kovai Medical Centre ConsultantCardiologist, 0422-4323124 Chockalingam and Hospital Deptof Cardiology,P.B. 0422-4214020 No: 3209, Avanashi [email protected] Road, Peelamedu,-641014 Coimbatore TAMIL NADU Dr. G.Rajasekhar Mediciti Hospitals 5-9-22, Secretariat +914023231111 Reddy Road,-50003 Hyderabad ANDHRA PRADESH Dr B .Ramesh Babu Medwin Hospitals Raghava 040-23206666 Towers,Chirang Ali 040-23204053 Lane-500001 medwin_research@yah Hyderabad oo.co.in ANDHRA PRADESH Dr. Pradeep Kumar Narayana Hrudayalaya 258/A, 09886063735 Bommasandra,Industria 080-7835208 l Area-560099 [email protected] Bangalore o.in KARNATAKA Dr. Mukund Kumbla Omega Hospital Mahaveer Circle,Kanka 0824-2430000 nady-575002 0824-2432925 Bangalore [email protected] KARNATAKA m Dr. R.B. Gulati Ruby Hall Clinic Sasoon 020-66455245 Road,Pune-411001 020-26051177 Pune [email protected] MAHARASHTRA Dr. Raja Babu Panwar S. P. Medical College & ,-334003 0151 2525451 A. G. Hospitals Bikaner RAJASTHAN clindocbhawani@yahoo .co.in Dr. S. C. Sinha Seven Hills hospitals, Rockdale +918912708090 Layout,-530002 Not Applicable page 3 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in N/A Dr Nitish Garg Tagore Heart Care and Banda Bahadur 0181-2204408/ Research Centre Nagar,Mahavir Marg 2204123 -144008 0181-2204408/ Jalandhar 2204123 PUNJAB [email protected] Dr. Ajay Naik The Heart Care Clinic 201 Balleshwar, 079-26873101 Avenue, Opp. Rajpath 079 26872620 Club- 380054 Manisha.rajan@vibgyor Ahmadabad car.com GUJARAT Dr C.B. Keshavamurthy Vikram Hospital and 46, Vivekananda Road, 0821-2412121 Heart Care Yadavagiri-570020 0821-4255533 Mysore [email protected] KARNATAKA Dr. P .S. Gautam Yashoda Hospitals Raj Bhavan Road, 040-23319999 Somajiguda,-500082 040-23370655/2331278 Hyderabad 3 ANDHRA PRADESH Gautamps1@rediffmail. com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Bankers Ethics Approved No Date Specified Not Available Committee, Vadodara Clinical Trial Ethics Approved No Date Specified Not Available Committee, Bhatia Hospital, Mumbai Ethical/Research Approved No Date Specified Not Available Committee, Narayana Hrudayalaya, Bangalore Ethics Comittee of the Approved No Date Specified Not Available heart Clinic, Ahemdabad Ethics Committee, Approved No Date Specified Not Available Apollo Hospitals Internation Ltd, Gandhinagar Ethics Committee, Approved No Date Specified Not Available Apollo Hospitals International Ltd, Gandhinagar Ethics Committee, Approved No Date Specified Not Available Apollo Speciality Hospitals, Madurai Ethics Committee, G. Approved No Date Specified Not Available Kuppuswamy Naidu Memorial Hospital, Coimbatore Ethics Committee, Approved No Date Specified Not Available Kamineni Wockhardt Hospitals, hyderabad Ethics Committee, Approved No Date Specified Not Available Poona Research Foundation, Ruby Hall Clinic, Pune page 4 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Ethics Committee, S. P. Approved No Date Specified Not Available Medical College & A. G. Hospitals, Bikaner Ethics Committee, Approved No Date Specified Not Available Seven Heals Hospitals, Vishakhapatanum Ethics Committee, Approved No Date Specified Not Available SHARE Organisation, Mediciti Hospital, Hyderabad Ethics Committee, Approved No Date Specified Not Available Surat Medical Association Hall, surat Ethics Committee, Approved No Date Specified Not Available Tagore Heart Care and Research Centre, Jalandhar Independent Ethics Approved No Date Specified Not Available Committee, Escorts Heart Institute & Research Center, Delhi Institutional Ethics Approved No Date Specified Not Available Comittee, KEMHRC, Pune Institutional Ethics Approved No Date Specified Not Available Committee Global Hospital, Hyderabad Institutional Ethics Approved No Date Specified Not Available Committee, Dinanath Mangaeshkar Hospital and research Centre, Pune Institutional Ethics Approved No Date Specified Not Available Committee, JSS Medical College and Hospital, Mysore Institutional Ethics Approved No Date Specified Not Available Committee, Medwin Hospital, Hyderabad Institutional Ethics Approved No Date Specified Not Available Committee, YAMER Yashoda Hospitals, Secunderabad KMCH Ethics Approved No Date Specified Not Available Committee, Kovai Medical Centre and Hospital, Coimbatore Mallikatta Ethics Approved No Date Specified Not Available Committee, Mangalore Vikram Hospitals Ethics Approved No Date Specified Not Available Committee, Mysore Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied Atrial Fibrillation Stroke page 5 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Intervention / Type Name Details Comparator Agent Intervention Rivaroxaban (Xarelto, 20 mg once daily*(*Subjects BAY59-7939) with moderate renal impairment at screening will receive 15 mg once daily) Comparator Agent Rivaroxaban 20mg p.o. once daily Comparator
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