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1 Clinical Trial Details (PDF Generation Date :- Mon, 24 Dec :41:15 GMT) CTRI Number Last Modified On 10/12/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 24/07/2012] - Trial Registered Prospectively Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK ) A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) MK dated 24 May 2012 NCT Designation Affiliation Address Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Address Details Contact Person (Scientific Query) Mr Anirban Roychowdhury GCTO Lead - MSD Pharmaceuticals Pvt. Ltd. Phone Fax Designation Affiliation Address MSD Pharmaceuticals Pvt. Ltd. 6th Floor, Tower B, Vatika Towers, Golf Course Road, Sec-54 Gurgaon HARYANA anirban.roychowdhury2@merck.com Details Contact Person (Public Query) Mr Anirban Roychowdhury GCTO Lead - MSD Pharmaceuticals Pvt. Ltd. Phone MSD Pharmaceuticals Pvt. Ltd. 6th Floor, Tower B, Vatika Towers, Golf Course Road, Sec-54 Gurgaon HARYANA page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Merck & Co. Inc., Global Headquarters One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Phone: Primary Sponsor Details Merck Sharp and Dohme Address One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Type of Sponsor MSD Pharmaceuticals Pvt Ltd List of Countries China Hong Kong Taiwan of Principal Investigator Dr Sudhir Kumar Bhatnagar DrRamesh Babu Dr A K Awasthi Pharmaceutical industry-global Address MSD Pharmaceuticals Pvt Ltd, Vatika Tower-B, Sec - 54, Gurgaon , Haryana of Site Site Address Phone/Fax/ Abhinav Multispeciality Abhinav Multispeciality Kamal Chok,Nera Indra Square, Maharashtra, , Kamal Chok,Nera Indra Square, Maharashtra, , drsudhirbhatnagar@gm ail.com dr_rameshbabu_p@ya hoo.co.in Ajanta Research Centre Ajanta and IVF Centre, 765 ABC Complex, Alambagh, dr.ak_awasthi@yahoo.c Lucknow , U.P. om Lucknow UTTAR PRADESH Dr Jaspal Arneja Arneja Heart Institute Interventional Cardiology, 123, Ramdaspeth, Maharashtra, Dr Ravindra Kulkarni Dr Poonam Lavhe Ashwin Medical Foundation s Avanti Institute of Cardiology jaspalarneja_200@yah oo.com Moraya Multispeciality , Chinchwadgaon, Pune - drravindrakulkarni@gm ail.com Pune 5 Abhyankar Road, Dhantoli,, Maharashtra, pons_gmc@yahoo.com page 2 / 8

3 Dr Hemant Thacker Bhatia G1 Ward, Tardeo, Mumbai, Maharashtra,., Mumbai Dr Abraham Ooman Dr Ashokan Nambiar Dr Arun Chopra Dr H K Bali Dr Subramanyam K Dr Veerappa Annasaheb Kothiwale Dr Nagamalesh Dr Rituparna Shinde Cardiology, Apollo Tondiarpet Cardiology, BABY MEMORIAL HOSPITAL LIMITED Cardiology, Fortis Escort Cardiology, Fortis Cardiology, Justice K. S. Hegde Cardiology, KLES Dr. Prabhakar Kore Cardiology, M.S.Ramaiah Memorial Cardiology, Sanjeevan 645/646th, T. H. Road, Tondiarpet, Chennai Tamil Nadu, Chennai TAMIL NADU Indira Gandhi Road, Calicut , Kerala, Kozhikode KERALA drhpt@hotmail.com drabrahamoomman@g mail.com hrdya44@yahoo.com Majitha Verka, Bypass Road, Amritsar, Punjab, akchopra1@rediffmail.c Amritsar om PUNJAB Sector 62, Phase 8, Mohali Punjab,, Patiala PUNJAB Deralakatte, Mangalore Dakshina Kannada Nehru Nagar, Belgaum, Belgaum hkpgi@gmail.com drsubramanyam@rediff mail.com nov10kothiwale@yahoo.co.in MRTS Post, New BEL Road, Bangalore ,Karnataka, nmalesh@yahoo.co.in Bangalore Kashibai Khelkar, Erandwane Pune Pune Dr Anil Saxena Dept of Cardiology Fortis Escorts Heart Institute, Okhla Road, New Delhi,, New Delhi DELHI Dr Anoop Gupta Dept of Cardiology Sterling, Sterling Road, Memnagar, Ahmedabad, Gujarat, Ahmadabad GUJARAT ritushinde@gmail.com anil.saxena@hotmail.co m anoopgupta@msn.com Dr Kartikeya Bhargava Dept of Cardiology Medanta- The Medicity, page 3 / 8

4 Dr Jitendra Pal Sawhney Anand Valsakumar Dr Sandeep Kumar Gupta P Naveen Chander Reddy Dharma vira Heart Center Lakeshore & Research Centre Ltd. M.V. and Research Center Sector-38, Gurgoan, Haryana , Gurgaon HARYANA Sir Ganga, Old Rajinder Nagar, New Delhi, New Delhi DELHI kartikeya.bhargava@m edanta.org jpssawhney@yahoo.co m PI, Lakeshore & Research Centre Ltd NH 47 Bypass, Maradu, anandheart@gmail.com Nettoor P.O Kochi, Ernakulam KERALA 314/30, Mirza Mandi, Chowk, Lucknow, Uttar Pradesh,, Lucknow UTTAR PRADESH Mediciti s Mediciti s , Secretariat Road Hyderabad Hyderabad ANDHRA PRADESH sandeepkumar.gupta@ rediffmail.com prodduturnaveen@yah oo.co.in Dr Narendra Jathappa Nanjappa Life Care # 5619, GadiKoppa, Sagar Road, Shivamogga Karnataka, jnarendra2009@gmail.c om Bangalore Dr AG Ravikishore Narayana Hrudayalaya 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore Karnataka, , Bangalore Dr Shantanu Sengupta Dr Shomu Bohora Dr Mahesh Chandulal Fulwani Sengupta & Research Institute Sengupta & Research Institute Shri Krishna Hrudayalaya And Critical Care Centre Ravinagar Square,, Maharashtra,, Ravinagar Square,, Maharashtra,, Opp. New English School, Congress, Nagar Tikekar Road, Dhantoli,,, ravikishoreag@yahoo.c o.in senguptasp@gmail.co m shomubahora@yahoo.c om maheshfulwani@yahoo. co.in Dr Nitish Garg Tagore and Banda Bahadur Nagar, page 4 / 8

5 Details of Ethics Dr PP Mohanan Heart Care Centre (P) Ltd. West Fort Hi -Tech Ltd Mahavir Marg, Jalandhar , Punjab Jalandhar PUNJAB Palliative Care Unit, Punkunnam, Thrissur Kerala, Thrissur KERALA drnitishgarg@gmail.co m drppmohanan@gmail.c om of Approval Status Date of Approval Is Independent Ethics? Axiom Lifesciences Independent Ethics, Pune-Dr Kulkarni Baroda Heart Institute Ethics -Dr Shomu Bohora Bio Ethics Forum of Lucknow, Lucknow-Dr Awasthi Central Ethical Central Medical Research Ethics, -Dr Fulwani Central Medical Research Ethics -Dr Arneja Citi Cardiac Research Centre Ltd, Institutional Ethics -Dr RAmesh Babu Clinical Trial Ethics,Bhatia Mumbai-Dr Thacker EC-Ethics Ethics Ethics of Avanti Institute of Cardiology-Dr Poonam Ethics of KLE university-dr kothiwale Ethics,Baby Mamorial Kozhikode-Dr Nambiar I.E.C Consultants, Bangalore-Dr J Narendra Approved 18/10/2011 Yes Approved 18/07/2011 Approved 11/09/2011 Yes Date Specified Approved 10/08/2012 Yes Approved 01/09/2011 Yes Approved 14/10/2011 Approved 12/08/2011 Date Specified Date Specified Approved 18/08/2011 Approved 22/09/2011 Approved 12/08/2011 Approved 20/07/2011 Yes Institute Ethics Date Specified page 5 / 8

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Institutional Ethics Institutional Ethics for M.V. and Research Center-Dr Sandeep Institutional Ethics,Westfort Hitech -Dr Mohnan M.S.Ramaiah Medical College and s Ethical Board-Dr Nagamalesh Medanta Independent Ethics Independent Ethics, -Dr Bhatnagar Independent Ethics, -Dr Sengupta Narayana Hrudayalaya Medical Ethics -Dr Ravikishore New Ethics Sterling Ethics -Dr Anoop Gupta Tagore & Heart Care Centre Ethics -Dr Nitish Garg The Independent Ethics Status Date Specified Approved 10/07/2011 Approved 16/09/2011 Approved 04/10/2011 Date Specified Approved 01/09/2011 Yes Approved 21/07/2011 Yes Approved 21/07/2011 Date Specified Approved 26/07/2011 Approved 16/08/2011 Date Specified Date Approved/Obtained 02/05/2012 Health Type Patients Patients Patients Condition Atrial Fibrillation Unspecified atrial fibrillation and atrial flutter Unspecified atrial fibrillation and atrial flutter Type Details Intervention vernakalant hydrochloride Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. Frequency: If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered. Route of page 6 / 8

7 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Comparator Agent Age From Age To Gender Details Details Placebo to vernakalant hydrochloride Year(s) Year(s) Both Computer generated randomization Centralized Inclusion Criteria administration: Intravenous infusion Dose:Patients will receive a 3 mg/kg infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg placebo will be administered. Each infusion will be given over 10 minutes. Frequency: 2nd infusion will be given (if required) 25 minutes after the start of the first infusion. Route of administration: Intravenous infusion - Abstinent or willing to use 2 acceptable methods of birth control - Patient has an atrial arrhythmia with dysrhythmic symptoms - Patient is receiving adequate anticoagulant therapy - Patient has stable blood pressure - Patient weighs between 45 and 136 kg (99 and 300 lbs) - Patient is adequately hydrated. Exclusion Criteria - Patient is pregnant, breast-feeding, or expecting to become pregnant during the study - Patient routinely consumes more than 2 alcoholic drinks per day - Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome - Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker - Patient has severe aortic stenosis - Patient has atrial flutter - Patient has Class IV congestive heart failure (CHF) - Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS) - Patient has had cardiac surgery within 30 days - Patient has known atrial thrombus - Patient has reversible causes of Atrial Fibrillation - Patient has failed electrical cardioversion during current episode of Atrial Fibrillation - Patient has uncorrected electrolyte imbalance - Patient has clinical evidence of digoxin toxicity - Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days - Patient is known to be HIV positive - Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers -Ejection Fraction 35%. page 7 / 8

8 Powered by TCPDF ( PDF of Trial Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: ] Proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: ] Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Time to conversion of Atrial Fibrillation to sinus Within 90 minutes after first exposure rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: ] Total Sample Size=615 Sample Size from =220 07/09/ /09/2012 Years=3 Months=4 Days=0 Other (Terminated) Other (Terminated) t Applicable currently The trial will be conducted in, Korea, China, Taiwan, HongKong.Expected date of enrollment for is 1-Aug-2012 & target sample size is 220. This multi center study is a double blind, placebo controlled, randomized study in patients with symptomatic Atrial Fibrillation at baseline of greater than 3 hours and up to 7 days. Eligible patients will be randomized in a 1:1 ratio to either MK 6621 or placebo. Primary outcome is Proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure. Time to conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure. page 8 / 8