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1 Clinical Trial Details (PDF Generation Date :- Tue, 24 Jul :13:40 GMT) CTRI Number CTRI/2009/091/ [Registered on: 13/05/2009] - Last Modified On 21/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) CV NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Raphael Pak PhD Study Director/ Central Medical Monitor Pfizer Global Research & Development 2800 Plymouth Road Ann Arbor, MI USA Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Other Raphael.Pak@pfizer.com Details Contact Person (Scientific Query) Dr Vinod Mattoo Medical Director Bristol-Myers Squibb Phone Fax Designation Affiliation Bristol-Myers Squibb India Pvt Ltd The Indiabulls Finance Centre, 6th Floor, Tower-1, Senapati Bapat Marg, Elphinstone (W) Mumbai India vinod.mattoo@bms.com Details Contact Person (Public Query) Dr Manish Mistry Bristol-Myers Squibb India Pvt Ltd Lower Parel Mumbai India page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > This trial is being sponsored by Bristol-Myers Squibb. Type of Sponsor NIL List of Countries India of Principal Investigator Dr. Natrajan Sekar Dr.Venugopal Balaji Dr. K. R. Suresh Dr. P. C. Gupta Primary Sponsor Details This trial is being sponsored by BristolMyers Squibb Bristol-Myers Squibb co., USA Pharmaceutical industry-global of Site Site Phone/Fax/ Apollo hospital, Apollo Hospital, Bhagwan Mahaveer Jain Hospital Care Hospital, Hyderabad Department of Vascular Surgery, No 21,Greams lane, off Greams road TAMIL NADU Apollo Hospitals,21 Greams Lane,,Off Greams Road, TAMIL NADU Jain Institute of vascular sciences,,miller?s Road, Vasthnagar Cardiodovascular Department,Road No. 1, Banjara Hills Hyderabad ANDHRA PRADESH Dr Ravul Jindal Fortis Hospital Super speciality in Heart Sector 62,Phase VIII, Mohali Patiala PUNJAB Dr Bishav Mohan Dr Kayanoosh Kadapatti Hero DMC Heart Institute (HDHI) Jahangir Clinical Development Center Pvt. Ltd. 3rd Floor, Department of Cardiology, Civil Lines, Tagore Nagar Ludhiana PUNJAB Jehangir Clinical Development Centre Pvt. Ltd. Jehangir Hospital Premises, 32, Sassoon Road, Pune spectra_chen@vsnl.net ravul.jindal@fortishealth care.com bishav_68@yahoo.co.in drkayanoosh@gmail.co m page 2 / 6

3 Details of Ethics Committee Dr NK Bhagwan Dr Rajiv Parakh Dr Sanjay Desai Dr Rajesh S Manipal Hospital, , Maharashtra, India. Pune Manipal Hospital, 6th Floor Clinical Research Department Near Dental Section, 98,HAL,Airport Road Medanta - The medicity Department of vascular and endovascular Surgery,Medanta & Medicity, Sector 38, Gurgaon Gurgaon HARYANA MS Ramaiah Memorial Hospital Narayana Hrudayalaya Hospitals Dr Ramakrishna Pinjala Nizams Institute of Medical Sciences Dept of Vascular Surgery M. S. Ramaiah Memorial Hospital New B.E.L. Road, M.S. Nagar, MSRIT Post , Karnataka, India # 258 A, Bommasandra Industrial Area, Anekal Taluk, Punjagutta,Hyderbad Hyderabad ANDHRA PRADESH Dr Dhanesh Kamerkar Ruby Hall Clinic Ruby Hall Clinic, Dept. of Vascular Surgery,40 Sassoon Road Pune Dr Ganesh Kamath Shridi Sai Baba Cancer Hosptial Manipal Acunova Ltd, 4th Floor, Shridi Sai Baba Cancer Hospital, Manipal , Karnataka Udupi nkbhagavan@yahoo.co m rparakh1@yahoo.co.in scdesai@hotmail.com rajeshsrinivas5@rediff mail.com pinjala@hotmail.com dhaneshkamerkar@gm ail.com sevagur@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? BMJH Ethics Committee on Human research/ / Dr. KR Suresh Ethics Committee Apollo Hospital/ Approved 09/03/2010 Not Available Approved 14/06/2010 Not Available page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent / Dr. S. Natrajan Ethics Committee Apollo Hospital/ / Dr. V Balaji Ethics Committee of Manipal Hospital & Manipal Heart Foundation/ / Dr. NK Bhagavan Ethics committee SGRH/ Haryana/ Dr R Parakh Institutional Ethical Committee Care Foundation/ Hyderabad/ Dr. PC Gupta Approved 12/08/2008 No Approved 12/11/2010 Not Available Approved 14/07/2009 Not Available Approved 06/06/2010 Not Available Institutional Ethics Approved 01/07/2010 No Committee (DTEC)/ Ludhiana/ Dr. B. Mohan Institutional Ethics Committee Nizams Institute/ Hyderabad/ Dr. R. Pinjala Institutional Ethics Committee Poona Medical & Research foundation/ Pune/ Dr. D. Kamerkar Institutional Review Board Fortis Hospital/ Mohali/ Dr. R Jindal MS Ramaiah Medical College & Teaching Hospital Ethical Review Board/ / Dr S Desai University Ethics Committee/ Manipal/ Dr G Kamath Status Approved 04/07/2009 Not Available Approved 02/02/2010 Not Available Approved 25/05/2009 Not Available Approved 10/06/2009 No Approved 18/11/2008 Not Available Date Approved/Obtained 27/11/2008 Health Type Patients Condition Symptomatic Deep Vein Thrombosis and Pulmonary Embolism Type Details Intervention Apixaban Drug: Placebo for enoxaparin solution, subcutaneous, 1 mg/kg Q12h until sham INR?2, twice daily Drug: Placebo for warfarin tablets, oral, dosing to target sham INR range between , once daily, 6 months Drug: apixaban tablets, oral, 10 mg tablets, twice daily, for 7 days page 4 / 6

5 Inclusion Criteria Exclusion Criteria followed by apixaban 5 mg, twice daily, 6 months. Comparator Agent Enoxaparin Drug: Enoxaparin solution, subcutaneous, 1 mg/kg Q12h until INR?2, twice daily Drug: warfarin tablets, oral, dosing to target INR range between , once daily, 6 months Drug: Placebo for apixaban tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months Age From Age To Gender Details Details Inclusion Criteria Men and women 18 years of age Clinical diagnosis of DVT or PE Exclusion Criteria Contraindications for enoxaparin or warfarin Active bleeding or high risk for serious bleeding Short life expectancy Uncontrolled high blood pressure Significantly impaired kidney or liver function Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Other Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] 6 months 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) Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] Total Sample Size=2408 Sample Size from India=405 01/09/ /03/2009 Years=4 Months=0 Days=0 Completed Completed 6 page 5 / 6

6 Powered by TCPDF ( PDF of Trial Publication Details Brief Summary NA The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE. India is part of this global trial. Globally and in India recruitment has started. page 6 / 6