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1 Clinical Trial Details (PDF Generation Date :- Mon, 18 Mar :52:56 GMT) CTRI Number CTRI/2009/091/ [Registered on: 13/10/2009] - Last Modified On 30/11/2013 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, Placebo Controlled Trial A Phase II clinical trial to study the effects of TRC4186, an investigational new drug in patients with stable heart failure associated with HbA1C? 6.0% or type 2 diabetes mellitus receiving oral anti-diabetic drug with or without insulin. Safety and Efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1C? 6.0% or type 2 Diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EudraCT CT/P004/HF/08/02_01 Designation Affiliation Protocol Number Details of Principal Investigator Dr. Ambrish K Srivastava Phone Fax Designation Affiliation Torrent Research Centre Village: Bhat Gandhinagar ambrishsrivastava@torrentpharma.com Details Contact Person (Scientific Query) Dr. Ambrish K Srivastava Phone Fax Designation Affiliation Torrent Research Centre Village: Bhat Gandhinagar ambrishsrivastava@torrentpharma.com Details Contact Person (Public Query) Dr. Ambrish K Srivastava Torrent Research Centre Village: Bhat Gandhinagar page 1 / 7

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 > Torrent Pharmaceutical. Ltd. Torrent House, Off Ashram Road, Ahmedabad Type of Sponsor NIL List of Countries of Principal Investigator Dr. Neelkanth Karandikar Dr. K. K. Haridas Dr. Jayesh Prajapati Dr. Uday Mahorkar Primary Sponsor Details Torrent Pharmaceutical Ltd Torrent Pharmaceutical Ltd. Torrent House,Off Ashram Road,Ahmedabad Gujarat Pharmaceutical industry-n of Site Site Phone/Fax/ Alpha Multispeciality Diagno Centre & Clinic Pvt. Ltd., Amrita Institute of Kochi Apollo Hospital, Ahmedabad Avanti Institute of Cardiology, Nagpur Dr A. Sreenivas Kumar CARE Hospital, Dr. Ramagiri Balaji Dr. Satej Janorkar DDH-KPR Heart & Lung Centre, Durgabai Deshmukh Hospital & Research Centre, Deenanath Mangeshkar Hospital and Research Centre, Not Applicable N/A Ahmadabad Nagpur Dr. Sukumar Ghosh IPJMER, Kolkatta Not Applicable N/A Dr. Umesh Akkalkotkar Dr. Abhijeet Joshi Dr Dilip Kumar Jahangir Clinical Development Centre Pvt. Ltd, Joshi Polyclinic & Heart Care Centre, Medica Superspeciality Hospital, Kolkata 127, Mukundapur, E. M. Bypass, Kolkatta Kolkata WEST BENGAL dilip.kumar@medicasyn ergic.in page 2 / 7

3 Details of Ethics Committee Dr. Manish Agrawal Dr. Ravindra Kulkarni Dr. S. P. Grover Dr. Sarat Chandra Medilink Hospital & Research Centre Pvt Ltd., Ahmedabad Moraya Multispeciality Hospital, New Ruby Hospital Pvt. Ltd, Jalandhar Nizam's Institute of Ahmadabad Jalandhar PUNJAB Dr. S. S. Mukharjee Prime Hospital, Dr. Purvez K. Grant Ruby Hall Clinic, Dr. Kajal ganguly S. G. Clinic, Kolkata Kolkata WEST BENGAL Dr. Suhas Kalashetty Dr. V. P. Sharma Dr. H. M. Mardikar Dr. Rajiv Garg Shree Samarth Hospital, Shri Ram Cardiac Center, Joshi Hospital, Jalandhar Spandan Heart Institute & Research Centre, Nagpur Yashoda Hospital, Malakpet, Dr. Athuluri Ravi Kanth Yashoda Hospital, Somajiguda, Jalandhar PUNJAB Nagpur of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apollo Hospital International Ltd, Ahmedabad Care Foundation - Committee, Care Hospital - Hydrabad. (Dr. Abheejeet joshi) (Dr. Aziz khan, Crescent Hospital, Nagpur) (Dr. Ravindra kulkarni, Moraya hospital, ) (Dr. Suhas Kalashetti, Approved 18/12/2010 No Approved 18/10/2009 No Approved 18/10/2010 Yes Approved 30/08/2010 Yes Approved 24/09/2010 Yes Approved 30/08/2010 Yes page 3 / 7

4 Shree samarth hospital, ) Ethics committee, Amrita Institute of Kochi Avanti Institute of Cardiology, 5-Abhyankar Road, Dhantoli, Nagpur Maharastra,. DDH-KPR Heart and Lung Centre, DDH Hospital, Jehangir Clinical Development Centre, Medica Superspeciality Hospital, Kolkatta Nizams Institute of Spandan Heart Institute and Research Center, 31, Off chitale marg, Dhantoli, Nagpur , Maharastra,. Independent Ethics Committee, Mumbai (Dr. V. P. Sharma, Joshi hospital, Jalandhar) Institute of post graduate medical education & research, Kolkatta Committee, Deenanath Mangeshkar Hospital and Research Centre,. Committee, Prime Hospital, Committee, Yashoda hospital, Malakpet, committee, Yashoda Approved 11/05/2010 No Approved 16/04/2009 No Approved 29/11/2010 No Approved 17/11/2010 Yes Approved 16/11/2010 No Approved 14/11/2010 No Approved 15/01/2010 No Approved 23/09/2009 Yes Approved 09/11/2010 No Approved 29/10/2009 No Approved 06/12/2010 No Approved 27/10/2010 No Approved 27/10/2010 No page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent hospital, Somajiguda, Life care Institute of Medical Science & Research, Ahmedabad Medilink Institutuinal Ethics committee, Ahmedabad Poona medical research foundation (Dr. Purvez Grant, Ruby Hall Clinic, ) Jyothirmoy Pal, Kolkatta) Kajal Ganguli, Kolkatta) Neelkanth Karandikar, Alpha multispeciality diagnostic centre, ) Prabhatkumar, Heart Hospital, Patna) R.K. Agrawal, Patna) Approved 24/12/2010 Yes Approved 01/11/2010 No Approved 25/10/2010 No Approved 13/04/2011 Yes Approved 13/04/2011 Yes Ranjan Kumar, Shankar diabetes centre, Patna) Approved 13/04/2011 Yes S.P.S Grover, New Ruby Hospital Pvt Ltd, Jalandhar) Status Date Approved/Obtained 05/09/2009 Health Type Patients Condition Chronic heart failure associated with impaired glucose tolerance Type Details Intervention TRC mg BD for 2 weeks followed by 250 mg BID for 46 page 5 / 7

6 Inclusion Criteria Comparator Agent Placebo Placebo BID Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria weeks mg BD for 2weeks followed by 1000 mg BD for 46 weeks mg BD for 2 weeks followed by 2000 BD for 46 weeks Salient Inclusion Criteria Subjects of either sex, aged? 45 years. Subjects with chronic heart failure, stable for 6 weeks (NYHA class II or III) according to criteria of ESC and on stable medication for heart failure for at least 2 weeks prior to screening. Subjects with Type 2 diabetes mellitus (i.e. receiving oral therapy with or without insulin) or an impaired glucose tolerance (HbA1c should be? 6.0% at screening). Subjects with an NT-proBNP? 400 pg/ml (subjects with atrial fibrillation NT-proBNP? 1200 pg/ml) Subjects receiving at least loop, thiazide or thiazide like diuretic for treating HF Subjects able to undergo cardiopulmonary exercise testing Exclusion Criteria Details Exclusion Criteria Salient Exclusion Criteria CHF caused by myocarditis, cor pulmonale, congenital heart disease, constrictive pericarditis, or hypertrophic or restrictive cardiomyopathy. Acute coronary syndrome or coronary revascularization within 3 months Second-degree or third-degree heart block (unless treated with a pacemaker) Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term corticosteroids. Left ventricular assist device (or an activated minute ventilation pacemaker) Uncontrolled hypertension (systolic blood pressure? 160 mmhg under antihypertensive treatment). Glomerular filtration rate (egfr) 30 ml/min. Unwilling or unable to comply with protocol Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Primary Efficasy End points: 1. Oxygen Uptake Efficiency Slope (OUES). 2. Physical Dimension of Minnesota Living with Heart Failure Questionnaire (MLHFQ). At Screening, Baseline, Week 24 and Week 48. Secondary Outcome Outcome Timepoints 1. NT-proBNP levels. 2. Peak VO2. 3. NYHA classification. 4. Significant & persistent change in diuretic dosage, anytime during the therapy At Screening, Baseline, Week 2, 4, 12, 24, 36 and 48. page 6 / 7

7 Powered by TCPDF ( Target Sample Size Phase of Trial Phase 2 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 persistence: 2 weeks dose changes : loop diuretics - 40 mg furosemide and 1 mg bumetanide, toresemide 10 mg or change from thiazides to loop diuretics or combination of thiazides and loop diuretic. 5. Impedance Cardiography (ICG) parameters. 6.Conventional and tissue Doppler echocardiography (at rest. 7. Oxygen Cost Diagram (OCD) Total Sample Size=300 Sample Size from =260 17/11/ /11/2009 Years=3 Months=0 Days=0 Completed Completed This study was a randomized, double blind, parallel group, multi-centre trial to evaluate the safety and efficacy of TRC4186 in subjects with stable heart failure due to impaired glucose tolerance. This trial was conducted in, The Netherlands, UK, Serbia and Russia. page 7 / 7