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CTRI Number  CTRI/2010/091/000317 [Registered on: 08/04/2010]
Last Modified On: 16/01/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. 
Scientific Title of Study
Modification(s)  
A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2009-014290-40  EudraCT 
DU176b-D-U305  Protocol Number 
NCT00986154  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Shoibal Mukherjee 
Designation  Vice President, Medical  
Affiliation  Quintiles Research (India) Private Limited 
Address  8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India - 122002

Gurgaon
HARYANA
122002
India 
Phone  91-7838652395  
Fax    
Email  shoibal.mukherjee@quintiles.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Suchela Srivatsa 
Designation  Director – Clinical Operations  
Affiliation  Quintiles Research (India) Pvt. Ltd. 
Address  301-A-1, Leela Business Park MV Road, Andheri East, Mumbai 400059

Mumbai
MAHARASHTRA
400 059
India 
Phone  91-9820712114  
Fax  91-22-56774343  
Email  suchela.srivatsa@quintiles.com  
 
Source of Monetary or Material Support
Modification(s)  
Daiichi Sankyo Pharma Development 399 Thornall Street, Edison, New Jersey 08837, USA  
 
Primary Sponsor
Modification(s)  
Name  Daiichi Sankyo Pharma Development  
Address  399 Thornall Street,Edison,New Jersey 08837,USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Quintiles Research India Private Limited  B-101-106, Shapath IV, Sarkhej-Gandhinagar Road, Ahmedabad - 380051, Gujarat 
 
Countries of Recruitment
Modification(s)  
  Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Denmark
Estonia
France
Germany
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
New Zealand
Norway
Philippines
Poland
Portugal
Republic of Korea
Russian Federation
Singapore
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 36  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Narayanasamy Durairaj  Apollo speciality Hospitals,  Lake view road, ,K. K. Nagar, -625 020
Madurai
TAMIL NADU 
+ 91 452 2581157
+ 91 452 2581157
scrcmdu@yahoo.co.in 
Dr. Jaspal Arneja  Arneja Heart Institute  123, Ramdaspeth,,Behind Somalwar School-440 010
Nagpur
MAHARASHTRA 
+91 9823066007
+91 0712-2450539
jaspalarneja_200@yahoo.com 
Dr. Darshan Navinchandra Banker  Banker's Heart Institute  Near Tagore nagar, Opp Suryakiran Complex, ,Old Padra Road,-370 015
Vadodara
GUJARAT 
+91 265 2324004
+91 265 2327401
info@bankersheart.com 
Dr. Jaswant Patel  BD Mehta Mahavir Heart Institute,  Athwagate Circle, ,-395 003
Surat
GUJARAT 
+91 9825129555

jashpatel@hotmail.com 
Dr. Kalkunta R. Suresh  Bhagwan Mahaveer Jain Hospital  Millers Road,Vasanth Nagar-560 052
Bangalore
KARNATAKA 
+91 80 22208311

research_jainvascular@hotmail.com 
Dr Bharat Mody  Center for Knee and Hip Surgery,   101/103 Akashganga Complex, ,Race Course Circle, Near Vanijaya Bhavan-390 007
Vadodara
GUJARAT 
91-265-2353670
91-265-6623670
mail@centreforkneesurgery.com 
Dr. Sarvanan Sundararaj  Chennai Transplant Centre  Chennai Transplant Centre,Madras Medical Mission-600037
Chennai
TAMIL NADU 
+91 44 26565991
+91 44 26565959
sundararaj.saravanan@gmail.com  
Dr Ashish Vasant Deshpande  Ciigma Institute of Medical Sciences Pvt Ltd  3, Raghuveer Nagar, Opp SFS High School, Jalna Road, Aurangabad, Maharashtra 431001
Aurangabad
MAHARASHTRA 
91-9850065964
91-240-2363792
ash_desh21@yahoo.com 
Dr Prabhakar Shetty  Columbia Asia Referral Hospital  #26/1, Yeshwantpur, Brigade Gateway, Dr. Rajkumar Road, Malleshwaram West, Bangalore, Karnataka 56005
Bangalore
KARNATAKA 
91-9731888404
91-80-39898969
pheggunje@gmail.com 
Dr Rajesh Jain  Convenient Hospitals Ltd.  CHL-Hospitals, A. B. Road, Near L.I.G Square, Indore- 452008
Indore
MADHYA PRADESH 
91-731-662111
91-7312549095
rajesh@chl-apollo.com 
Dr Sanjib Sahu  Durgabai Deshmukh Hospital and Research Centre  Durgabai Deshmukh Hospital,Andhra Mahila Sabha, VidyaNagar, Osmania University Road -500003
Hyderabad
ANDHRA PRADESH 
91-9849478860
91-40-27600307
skscard@yahoo.co.in 
Dr. Ravul Jindal   Fortis Hospital  Fortis Hospital,Phase VIII, Mohali-160062
Chandigarh
CHANDIGARH 
91 172 5096101
91 172 5096177
jravul@yahoo.com 
Dr. Nagabhushan K N  Fortis Hospitals Ltd.  Fortis Hospitals Ltd.,154/9, Bannerghatta Road-560 076
Bangalore
KARNATAKA 
+91 80 6621 4120
+91 80 66214873
nagbushankn@yahoo.com 
Dr. Kothiwale V  KLES Dr. Prabhakar Kore Hospital  KLES Dr. Prabhakar Kore Hospital,Nehru Nagar-590 010
Belgaum
KARNATAKA 
+91 9448119899
+91 831 2493011
nov10kothiwale@yahoo.co.in 
Dr Dayasagar Rao  Krishna Institute of Medical Sciences  1-8-31/1, Minister Road,Begumpet,Hyderabad, Andra Pradesh 500003
Hyderabad
ANDHRA PRADESH 
91-9849022989
91-40-27725000
dsrvala@rediffmail.com 
Dr Sanjay C Desai  M.S. Ramaiah Clinical Research Centre  First Floor, M.S. Ramaiah Advance Learning Center, Gnanagangothri Campus, Gate-4, New BEL Road, MSRIT Post, Bangalore-560054, Karnataka
Bangalore
KARNATAKA 
91-80-23609999

scdesai@hotmail.com 
Dr Sandeep Kumar Gupta  M.V Hospital and Research Centre  314/30, Mirza Mandi Chowk,Lucknow, Uttar Pradesh 22600
Lucknow
UTTAR PRADESH 
91-9336077839
91-522-2258215
sandeepkumar.gupta@rediffmail.com 
Dr N K Bhagavan  Manipal Hospital  Manipal Hospital,Dept of vascular surgery, HAL Airport Road,-560017
Bangalore
KARNATAKA 
91-9844041894
91-80-25207181
nkbhagavan@vsnl.net 
Dr Kumud Rai  Max Superspeciality Hospital  2 Press Enclave Road,,Saket,-110 017
New Delhi
DELHI 
91-11-26515050

kumud.rai@maxhealthcare.com 
Dr Rajiv Parakh  Medanta Medicity Hospital  Sector 38, Gurgaon, Haryana 122001
Gurgaon
HARYANA 
91-9811047390

rparakh1@yahoo.co.in 
Dr. Ravindra Kulkarni  Moraya Multispeciality Hospital       Moraya Multispeciality Hospital     ,Power House Chowk, Chinchwadgaon-411004
Pune
MAHARASHTRA 
09422300251 
+91 80 67306537
drravindrakulkarni@gmail.com 
Dr. Ravi Kishore A.G.  Narayana Hrudayalaya Hospital  Narayana Hrudayalaya Hospital,Near Bomasandra Industrial Area, Anekal Taluk-560099
Bangalore
KARNATAKA 
91 80 27835000
91 80 27835208
ravikishoreag@yahoo.co.in 
Dr Manish Raval  Niva Aks Life Sciences Pvt. Ltd   503, Shefali Centre, Paldi Cross Roads, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT 
9825066519
91-79-26576498
manish@vascularsurgeonahmedabad.com 
Dr. Ramakrishna Pinjala  Nizam's Institute of Medical Sciences,   Punjagutta,-500 082
Hyderabad
ANDHRA PRADESH 
+91 9848050243

pinjala@hotmail.com 
Dr Otikunta Naidu  Osmania General Hospital,   Department of Cardiology,, Afzalgun-500 012
Hyderabad
ANDHRA PRADESH 
91-9849826499
91-40-24736313
oadikesavanaidu@gmail.com 
Dr Shivram Bhonagiri  Pentagon Research Pvt Ltd., Pune  Pentagon Research Pvt Ltd,C/o. Medipoint Hosp. Pvt. Ltd., Aundh-411007
Pune
MAHARASHTRA 
91-9922441227
91-20-40098635
shivram.pentagon@gmail.com 
Dr Malipeddi Bhaskara Rao  Queen’s NRI Hospital  Garudwara Lane, Seethammadhara, Visakhapatnum- 530013, Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH 
91-9246624766
91-891-6617791
bhaskarstudies@hotmail.com 
Dr. Dhanesh R. Kamerkar  Ruby Hall Clinic,   40, Sassoon Road,,-411 001
Pune
MAHARASHTRA 
+91 20 26123391

dhaneshk@eth.net  
Dr. Surendra Agarwal  Sanjay Gandhi Hospital Post Graduate Institute of Medical Sciences,  Raebareli Road,-226 014
Lucknow
UTTAR PRADESH 
+91 9919002760
+91 522 2668017
surendra@sgpgi.ac.in 
Dr. Penurkar Mukund  Shashwat Hospital  Shashwat Hospital,22 Happy Colony, Kothrud-411 004
Pune
MAHARASHTRA 
+91 20 25452062
+91 20 25459386
mukund.penurkar@gmail.com 
Dr. Ghaisas Nitin  Shatabdi Super Speciality Hospital,  Suyojit City Centre,,Opp Mahamarg Bus Stand, Mumbai Naka,-422 005
Nashik
MAHARASHTRA 
+91 9823122892

nitin.ghaisas@gmail.com 
Dr. Hemanth Kumar  St John's Medical College  St John's Medical College,Sarjapura Road-560034
Bangalore
KARNATAKA 
+91 80 22065311
+91 80 25530070
dr_hemanth1@rediffmail.com 
Dr. Sushrut Sudhir Babhulkar  Sushrut Hospital research Center and Post Graduate Institute of Orthopaedics  Central Bazar road, ,Ramdaspeth-440 010
Nagpur
MAHARASHTRA 
+91 712 2524062
+91 712 2520065
sushrutbabhulkar@rediffmail.com 
Dr Pratik Desai  Vadodara Institute for Reconstructive Orthopaedic Care (VIROC)  5/B, Nivruti Colony, Aryakanya Vidhyalay Road, Karelibug, ,-390 018
Vadodara
GUJARAT 
91-9824261861

drjackiepatel@yahoo.co.in 
Dr. Vinod Madan Vijan  Vijan Cardiac & Critical Care Centre     Vijan Cardiac & Critical Care Centre   ,College Road-422005
Nashik
MAHARASHTRA 
+91 253-2572371
+91 253 2314786
vmvijan@hotmail.com   
Dr. Arun Srinivas  Vikram Hospital Pvt. Ltd.  46, Vivekanand Road, Yadavagiri, ,-570 020
Mysore
KARNATAKA 
+91 9845028387
+91 821 4255533
arunsrinivas@vivushealth.net 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 36  
Name of Committee  Approval Status 
Bankers Ethics Committee, Vadodara- Dr. Darshan Navinchandra Banker   Approved 
BMJH Ethics Committee on Human Research, Bangalore- Dr. Kalkunta R. Suresh   Approved 
CARE Hospital Ethics Committee, Vishakapattnam- Dr Malipeddi Bhaskara Rao  Approved 
Central India Medical Research Ethics Committee, Nagpur- Dr. Jaspal Arneja   Approved 
Ethical Review Board, M.S. Ramaiah Medical and Teaching Hospital, Bangalore- Dr Sanjay C Desai   Approved 
Ethics Committee Kodlikeri Memorial Hospital & Ciigma Hospital, 8, Manjeet Nagar, Oppp. Akashwani, Jalna Road, Aurangabad-431 005- Dr. Ashish Vasant Deshpande  Approved 
Ethics Committee of Biniwale Clinic, Pune - Dr. Penurkar Mukund   Approved 
Ethics Committee of Biniwale Clinic, Pune - Dr. Ravindra Kulkarni   Approved 
Ethics Committee of Krishna Institute of Medical Sciences, Minister road, Secunderabad- Dr. Dayasagar Rao  Approved 
Ethics Committee of Manipal Hospital & Manipal Heart Foundation, Bangalore- Dr N K Bhagavan  Approved 
Ethics Committee of the KLE University, Belgaum - Dr. Kothiwale V   Approved 
Ethics Committee, Apollo Speciality Hospitals, Madurai- Dr. Narayanasamy Durairaj   Approved 
Ethics Committee, Centre for Knee Surgery, Baroda - Dr Bharat Mody   Approved 
Ethics Committee, Fortis Hospital, Mohali- Dr. Ravul Jindal  Approved 
Ethics Committee, Narayana Hrudayalaya Hospitals, Bangalore- Dr. Ravi Kishore A.G.   Approved 
Ethics Committee, Osmania Medical College, Hyderabad- Dr Otikunta Naidu   Approved 
Fortis Hospital Ethics Committe, Bangalore- Dr. Nagabhushan K N   Approved 
Heart First Ethics Committee, Surat- Dr. Jaswant Patel  Approved 
Hyderabad Central Ethics Committee,# 12-13-392, Street No.: 1, Lane 4, Tarnara, Secunderabad- 500017- Dr. Sanjib Kumar Sahu  Approved 
Institutional Ethical Review Board, St. Johns Medical College and Hospital, Bangalore - Dr. Hemanth Kumar   Approved 
Institutional Ethics Committee for Human Research, Sanjay Gandhi post Graduate Institute of Medical Sciences, Lucknow- Dr. Surendra Agarwal  Approved 
Institutional Ethics Committee for M.V.Hospital and research centre, 314/30, Mriza Mandi, Chowk, Lucknow-226003- Dr.Sandeep Kumar Gupta  Approved 
Institutional Ethics Committee, Madras Medical College, Chennai- Dr. Sarvanan Sundararaj   Approved 
Institutional Ethics Committee, NIMS, Hyderabad- Dr. Ramakrishna Pinjala   Approved 
Institutional Ethics Committee- Poona Medical Research Foudation, Pune- Dr. Dhanesh R. Kamerkar   Approved 
Institutional Review Board, Max Devki Devi Heart and Vascular Institute, New Delhi- Dr Kumud Rai   Approved 
Integrity Ethics Committee, A. B. Road, Near L.I.G Triangle, Indore- 452008- Dr. Rajesh Jain  Approved 
Maanav Health Foundation, Independent Ethics Committee, A-1, Anupam Nagar, B/h. Rajvee Tower, Near Tube Company, O.P. Rd., Vadodara-390020- Dr. Pratik Desai   Approved 
Medanta Independent Ethics Committee, Medanta Medicity Hospital, Gurgaon- Dr Rajiv Parakh  Approved 
Penta-Med Ethics Committee, Medipoint Hosp. Pvt. Ltd., Aundh-411007- Dr Shivram Bhonagiri   Approved 
Safe Search Independent Ethics Committee, Ahmedabad- Dr Manish Raval   Approved 
Shatabdi Hospital Ethics Committee, Nasik- Dr. Ghaisas Nitin   Approved 
Sushrut Hospital Ethics Committee, Nagpur- Dr. Sushrut Sudhir Babhulkar  Approved 
The Institutional Ethics Committee Columbia Asia Hospitals, Columbia Asia Referral Hospital-Yeshwanthpur, #26/1, Brigade Gateway, Beside Metro, Malleshwaram West, Bangalore – 560 055- Dr. Prabhakar Shetty  Approved 
Vijan Hospital Ethics Committee, Vijan Cardiac & Critical Care Centre, Nashik- Dr. Vinod Madan Vijan  Approved 
Vikram Hospital Ethics Committee, Mysore - Dr. Arun Srinivas   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute symptomatic proximal deep-vein thrombosis and/or symptomatic pulmonary embolism 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Edoxaban tosylate(DU-176b)   Tablet Edoxaban tosylate(DU-176b) for oral use, 30 mg, one or two tablets daily, maximum of 12 months treatment  
Comparator Agent  low molecular weight heparin and unfractionated heparin  LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

1) Male or female subjects older than the minimum legal adult age (country specific);
2) Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
3) Able to provide written informed consent
 
 
ExclusionCriteria 
Details  1) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE; 2) More than 48 hours pre-treatment with anticoagulant therapy prior to randomization; 3) Calculated CrCL < 30 mL/min; 4) significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN; 5) patients with active cancer for whom long term treatment with (LMW) heparin is anticipated; 6) active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin; 7) chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs); 8) treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy; 9) concurrent treatment with potent P-gp inhibitors; 10) subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study  
 
Method of Generating Random Sequence
Modification(s)  
Stratified block randomization 
Method of Concealment
Modification(s)  
Centralized 
Blinding/Masking
Modification(s)  
Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
- Symptomatic recurrent VTE, i.e., the composite of DVT, non-fatal PE, and fatal PE   Time Frame: 12 months from time of randomization  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
- The composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and all-cause mortality
- Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment  
Time Frame: 12 months from time of randomization  
 
Target Sample Size
Modification(s)  
Total Sample Size="7500"
Sample Size from India="1000" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
15/05/2010 
Date of First Enrollment (Global)  28/01/2010 
Estimated Duration of Trial
Modification(s)  
Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None 
Brief Summary
Modification(s)  
This is a Phase 3, multi-national, multi-center, randomized, double-blind, matching placebo, parallel-group (2 treatment groups), non-inferiority study for efficacy. The maximum treatment period for any individual subject after randomization will be 12 months. While 12 months of treatment are planned, mitigating factors related to the subject?s clinical status will likely influence the total duration of treatment a given subject actually receives. Nevertheless, it is planned that all subjects will be administered a minimum of three months treatment consistent with current American College of Chest Physicians (ACCP) Guidelines. It is anticipated that approximately 10% of subjects will discontinue treatment after 3 months, an additional 40% will discontinue after 6 months, and 50% will complete the entire 12 months of treatment. Treatment durations will be monitored during the study, and the Steering Management Coordinating Committee (SMCC) will take appropriate action to ensure that an approximate proportion of subjects complete the treatment durations as indicated. Regardless of the total duration of study drug treatment actually received, efficacy and safety data will be collected on all subjects, including those who temporarily interrupt or permanently discontinue study drug, during the entire 12-month period following randomization. For all subjects, contacts (visits or phone calls) are scheduled at regular time points. During these contacts, the treatment and clinical course of the subject will be evaluated. Subjects with suspected efficacy or safety endpoints will undergo confirmatory testing. All subjects, including those who temporarily interrupt or permanently discontinue study drug, will be expected to have the following: - A Month 12 visit which is critical for the modified intent to treat (mITT) analysis of efficacy, - A safety follow-up visit approximately 1 month after the last dose of study drug. In this context, last dose means last dose before permanent study drug discontinuation (premature or at the scheduled end of treatment). Globally approximately 7,500 subjects will be randomized and in India 1000 subjects are targeted to be enrolled. The date of first patient enrollment in India is May 15, 2010. 
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