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CTRI Number  CTRI/2011/06/001844 [Registered on: 29/06/2011] Trial Registered Prospectively
Last Modified On: 13/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of dronedarone on Cardiac patients with permenant atrial fibrilation (i.e.irregular heart beat)  
Scientific Title of Study   A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400 mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors  
Trial Acronym  PALLAS 
Secondary IDs if Any  
Secondary ID  Identifier 
EFC 11405  Protocol Number 
NCT01151137  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Denis Xavier 
Designation  Professor and Head, Dept. of Pharmacology 
Affiliation   
Address  St Johns Medical College Principal Investigator - NIH Center of Excellence Coordinator Division of Clinical Trials St Johns Research Institute St Johns National Academy of Health Sciences Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  drdenisxavier@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Salini James 
Designation  Clinical project leader 
Affiliation   
Address  Sanofi Aventis India Limited

Mumbai
MAHARASHTRA
400093
India 
Phone  022-28278555  
Fax  022-28278059  
Email  Salini.James@sanofi-aventis.com  
 
Details of Contact Person
Public Query  
Name  Salini James 
Designation   
Affiliation   
Address  Sanofi Aventis India Limited

Mumbai
MAHARASHTRA
400093
India 
Phone  022-28278555  
Fax  022-28278059  
Email  Salini.James@sanofi-aventis.com  
 
Source of Monetary or Material Support  
Sanofi-Synthelabo (India) Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093  
 
Primary Sponsor  
Name  SanofiSynthelabo India Limited 
Address  54/A Sir Mathuradas Vasanji Road Andheri East Mumbai 400093  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Kazakhstan
Malaysia
Mexico
Netherlands
New Zealand
Norway
Philippines
Poland
Romania
Russian Federation
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Ukraine
United Kingdom
United States of America  
Sites of Study  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aftab Khan  Apollo Gleneagles Hospital   No 58 Canal Circular Road 700 054
Kolkata
WEST BENGAL 		 91-9831257844
033-23201739
cardiokhan@gmail.com 
Dr Lavhe Poonam  Avanti Institute of Cardiology   5 Abhyankar Road Dhantoli 440012
Nagpur
MAHARASHTRA 		 9850235284
0712-2461599
pons_gmc@yahoo.com 
Dr Dhiman Kahali  B M Birla Heart Research Centre  Dept. Of Clinical Research, B M Birla Heart Research Centre 1of1 National Library Avenue
Kolkata
WEST BENGAL 		 91-9830048563
033-24567006
dk.kahali@gmail.com 
Dr S S Ramesh  Bhagwan Mahaveer Jain Heart Center,  Department of Cardiology, # 8 Millars Tank Bund Road, Bangalore-560052
Bangalore
KARNATAKA 		 91-9845069514
080-41538708
ssramesh@vivushealth.net 
Dr GSR Murty   CARE Hospital   Waltair Main Road Ram Nagar 530003
Visakhapatnam
ANDHRA PRADESH 		 91-9989911178
0891-2714015
srmurtyg@hotmail.com 
Dr K Sharda  CARE Hospital   Opp Exhibition ground Nampally -500001
Hyderabad
ANDHRA PRADESH 		 91-9246535332
040-30417488
bksharada@yahoo.com 
Dr Suryaprakash  CARE Hospital   Near Clock Tower Makket Street Secunderabad 500003
Hyderabad
ANDHRA PRADESH 		 91-9949350369
040-27717738
suryaprakashgulla@gmail.com 
Dr Rajaneesh Calton  Christian Medical College  Professor and head Department of Cardiology Brown Road 141008
Ludhiana
PUNJAB 		 91-9878606736
0161-2228568
caltonrajneesh@yahoo.com 
Dr Aziz Khan  Crescent Hospital & Heart Centre  1st Lane Near Lokmat Square Dhantoli-440012
Nagpur
MAHARASHTRA 		 91-9823056551
712-2420698
khandraziz@yahoo.com 
Dr Shireesh Sathe  Deenananth Mangeshkar Hospital and Research Centre  Department of Cardiology, Erandwane Erandwane 411004
Pune
MAHARASHTRA 		 91-9822053216
020-25466584
shireesh@vsnl.com 
Dr Sawheny  Dharmavera Health Centre   5th Floor Dept of Cardiology Sir Gangaram Hospital Rajinder Nagar 110 060
New Delhi
DELHI 		 91-9810059773
011-42437231
jpssawhney@yahoo.com 
Dr Jitendra Singh Makkar  Fortis Escorts Hospital  Jawahar Lal Nehru Marg Malviya Nagar -302107
Jaipur
RAJASTHAN 		 91-9928544344
141-4008151
drjsm@hotmail.com 
Dr Sambasivam  G. Kuppuswami Naidu Memorial Hospital,  G. Kuppuswami Naidu Memorial Hospital, Coimbatore Tamil Nadu-641037
Coimbatore
TAMIL NADU 		 91-9363122394
0422-2243509
drsambasivam@yahoo.com 
Dr Sanjay Tyagi  Govind Ballabh Pant Hospital  Dept of Cardiology Govind Ballabh Pant Hospital Jawaharlal Nehru Marg -110 002
New Delhi
DELHI 		 91-9891356668
011-23235026
drsanjaytyagi@vsnl.com 
Dr Brian Pinto  Holy Family Hospital,  Department of Cardiology, St. Andrews Road, Bandra West, Mumbai-400050
Mumbai
MAHARASHTRA 		 91-9820054913
022-26452737
brianpinto@iifc.inf 
Dr Vijayaraghavan  Kerala Institute of Medical Sciences  Dept of cardiology 695029
Thiruvananthapuram
KERALA 		 0471-3041320
0471-2446535
drvijayaraghavan@gmail.com 
Dr Sudhanshu Dwivedi  King George Medical College   Chhatrapati Shahuji Maharaj Medical University Chowk 226003
Lucknow
UTTAR PRADESH 		 91-9935037620
0522-2255830
dr_skdwivedi@rediffmail.com 
Dr R K Jain  Krishna Institute of Medical Sciences  1-8-31/1, Minister Road, Secunderabad-500003
Hyderabad
ANDHRA PRADESH 		 91-9848029443
040-27845555
kumarpre@hotmail.com 
Dr Sameer Dani  Lifecare Institute of Medical Sciences & Research   At Sardar Patel Statue Stadium Road Naranpura 380014
Ahmadabad
GUJARAT 		 91-9825038855
079-40204304
danisameer@hotmail.com 
Dr Manoj Chopda  Magnum Heart Institute, Chopda Medicare & Research Pvt. Ltd  Patil Lane No. 1, Opp.Vasant Market,Canada Corner,-422005
Nashik
MAHARASHTRA 		 02532316200
0253-2316202
rush_manoj@yahoo.com 
Dr Viveka Kumar  Max Super Speciality Hospital   East block 1 Press Enclave road Saket 110017
New Delhi
DELHI 		 91-9871001190
011-26565060
viveka.kumar@maxhealthcare.com 
Dr Balbir Singh  Medanta-The Medicity  Department of Cardiology, Sector 38 122001
Gurgaon
HARYANA 		 91-9811102598
0124-4834208
drbalbirs@gmail.com 
Dr Abhijeeth Joshi  Niramaya Hospital  Near Chinchwad Post Poffice Behind Desai Petrol Pump Mumbai Pune Road Chinchwad Pimpri 411019
Pune
MAHARASHTRA 		 020-40098653
020-39841300
dr.abhijeetjoshi@yahoo.com 
Dr Nitin Patki  Pentagon Research Pvt Ltd   C/O Medipoint Hospitals Pvt Ltd 241by1 New DP Road Aundh 411007
Pune
MAHARASHTRA 		 020-40098653
020-39841300
nitin1patki@yahoo.com 
Dr J S Bhuvaneswaran  PSG Hospitals  HOD & Professor of Cardiology Peelalamedu 641004
Coimbatore
TAMIL NADU 		 91-9843015419
0422-4397910
drbhucbect@yahoo.in 
Dr Fulwani  Shri Krishna Hrudayalaya and Critical Care Center   Dr. S. M. Patils Clinic, Yugandharma Complex, Ramdaspeth Nagpur-440010
Nagpur
MAHARASHTRA 		 91-9823078146
712-2440120
maheshfulwani@yahoo.co.in 
Dr Ajit Kumar  SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES & TECHNOLOGY  Department of Cardiology, Sree Chitra Instutute for Medical Sciences and Technolgy, Trivandrum, Thiruvanathapuram, Kerala, India
Thiruvananthapuram
KERALA 		 91-9895153684
471-2550728
ajitkumarvk@yahoo.com 
Dr. C.B.Patil  St. John?s Medical College & Hospital  Cardiology Research Unit, Sarjarpur Road,-560034
Bangalore
KARNATAKA 		 09845116933
08025630603
drcbpatil@gmail.com 
Dr Anoop Gupta  Sterling Hospital   Department of Cardiology, Sterling Hospital Road, Memnagar-380 052
Ahmadabad
GUJARAT 		 091-9825611033
079-40011621
anoopgupta@msn.com 
Dr Tejas Patel  TCVS PVT LTD   Kedar 1st and 4th floor Near Parimal Garden 380006
Ahmadabad
GUJARAT 		 91-9824030576
079-26407711
drtpatel@tcvsgroup.org 
 
Details of Ethics Committee  
No of Ethics Committees= 30  
Name of Committee  Approval Status 
Ethics & Scientific Review Committee  Submittted/Under Review 
Central India Medical Research Ethics Committee  Submittted/Under Review 
Ethics Committee Christian Medical College  Submittted/Under Review 
Ethics Committee CSM Medical University  Submittted/Under Review 
Ethics Committee Institutional Ethics Review Board  Submittted/Under Review 
Ethics Committee of Sir Ganga Ram Hospital  Submittted/Under Review 
Ethics Committee of Avanti Institute of Cardiology  Approved 
Ethics Committee of Kerala Institute of Medical Sciences  Submittted/Under Review 
Ethics Committee of Life Care Institute of Medical Sciences  Submittted/Under Review 
Excel Society of Medical Science Ethics Committee  Submittted/Under Review 
Global Health Concern Ethics Committee  Submittted/Under Review 
Institute of Ethics Committee of CARE Hospital  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee Fortis Escorts Hospital  Submittted/Under Review 
Institutional Ethics Committee GKNMH  Submittted/Under Review 
Institutional Ethics Committee of Apollo Gleneagles Hospital  Approved 
Institutional Ethics Committee of CARE Hospital  Submittted/Under Review 
Institutional Ethics Committee of CARE Hospital  Submittted/Under Review 
Institutional Review Board Cardiac Research Academy & Srinivasa Cardiology Centre Pvt. Ltd.  Submittted/Under Review 
Institutional Review Board Max Super Speciality Hospital (East Block)  Submittted/Under Review 
KIMS Institutional Ethics Committee  Submittted/Under Review 
Maulana Azad Medical College Ethics Committee  Submittted/Under Review 
Medanta Independent Ethics Committee  Submittted/Under Review 
PENTA-MED Ethics Committee  Submittted/Under Review 
PENTA-MED Ethics Committee  Submittted/Under Review 
Sree Chitra Institutional Committee  Submittted/Under Review 
Sterling Hospital Ethics Committee  Submittted/Under Review 
Sujlam Independent Ethics Committee  Submittted/Under Review 
The Bandra Holy Family Medical Research Society  Approved 
The Institution Human Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Permanent Atrial fibriLLAtion , (1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dronedarone-Oral  400 mg- (twise a day ) for 2 years 3 months  
Comparator Agent  Placebo  Placebo 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients in permanent atrial fibrillation with additional risk
factors
2. Patients in permanent atrial fibrillation defined by the
presence of all of the following criteria:
1. Availability of one 12-lead ECG not more than 14
days prior to randomization, showing that the patient
is in atrial fibrillation or atrial flutter
2. Availability of documentation (including either rhythm
strips or medical report of the rhythm) showing that
the patient was in atrial fibrillation or atrial flutter at
least 6 months prior to randomization
3. No evidence of sinus rhythm in the period between
these two documentations of atrial fibrillation
4. Patient and physician decision to allow atrial
fibrillation to continue without further efforts to restore
sinus rhythm
5.Patients aged 65 years or older with at least one of the
following risk factors or combination of risk factors:
1.Coronary artery disease
2. Prior stroke or TIA
3. Symptomatic heart failure
4. Left ventricular ejection fraction less than or equal to
0.40
5. Peripheral arterial occlusive disease
6. Aged 75 years or older with both hypertension and
diabetes mellitus" 
 
ExclusionCriteria 
Details  "Exclusion Criteria (selection)
E 01. Patients in paroxysmal atrial fibrillation
E 02. Patients in persistent atrial fibrillation without a decision to
allow atrial fibrillation to continue without further efforts to
restore sinus rhythm
E 11. Patients with heart failure of NYHA class IV or recent
unstable NYHA class III" 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Composite endpoint of first stroke, systemic arterial embolism,
myocardial infarction or cardiovascular death
2.Composite endpoint of first unplanned cardiovascular
hospitalization or death from any cause 		 1.The Common Study End Date will be anticipated based on the
projected blind number of events to reach 844 coprimary events not
refuted by adjudication (stroke, systemic arterial embolism,
myocardial infarction or cardiovascular death) but cannot be less
than 3 months after the last patient randomized 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10800"
Sample Size from India="550" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/07/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Trial will be conducted in 43 countries all over the world. Globally study start date is July 2010. Globally estimated study competion date and estimated primary completion date is August 2013. The Indian target - 550 patients Indian status - 0 patients randomized till date Planned date of first enrolment - 04 July 2011 
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