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1 Clinical Trial Details (PDF Generation Date :- Mon, 02 Jul :26:32 GMT) CTRI Number CTRI/2009/091/ [Registered on: 08/09/2009] - Last Modified On 26/08/2015 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 clinical trial to study the effect of lixivaptan in the treatment of hyponatremia in NYHA Class III/IV Cardiac Patients The BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardioc Patient Evaluation Acronym: BALANCE 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) CK-LX3401 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Gurappa Shetty Gojanur Doctor Phone Fax Designation Affiliation St. Johns Medical College Hospital Dept of Cardiology, III Floor cardioresearch@gmail.com Details Contact Person (Scientific Query) Arati Patil Ms CRO performing the study Phone Fax Designation Affiliation DiagnoSearch Life SCiences Pvt. Ltd 101, First Floor, B.G. House, Orchard Avenue arati.patil@diagnosearch.com Details Contact Person (Public Query) Arati Patil Ms DiagnoSearch Life SCiences Pvt. Ltd 101, First Floor, B.G. House, Orchard Avenue 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 > Cardiokine Biopharma, LLC 30 S. 15th Street, 15th floor Philadelphia, PA Type of Sponsor NIL List of Countries United Kingdom United States of America of Principal Investigator Dr. Maniyal Vijayakumar Dr. Uday Mahorkar Dr. Keshava Ramaiah Dr. Hemant Thacker Dr. G. Surya Prakash Primary Sponsor Details Cardiokine Biopharma USA Pharmaceutical industry-global of Site Site Phone/Fax/ Amrita Institute of Medical Sciences and Research Centre Avanti Institute of Cardiology, Nagpur Bhagwan Mahaveer Jain Heart Centre, Bhatia Hospital, Mumbai Care Hospital, secundrabad Amrita Institute of Medical Sciences and Research Centre,Amrita Lane, Elamkara P.O. Kochi Avanti Institute of Cardiology, Pvt Ltd,5 Abhyankhar Road Cardiac Research Academy& Srinivasa Cardiology Centre Pvt Ltd,#8 Millers Tank bund Road KARNATAKA G-1 Block, Bhatia Hospital,Tardeo Road Mumbai MAHARASHTRA Dr. Rajesh Jain CHL-Appollo Hospitals A.B. Road,Near L.I.G. Triangle edu om CARE Foundation, CARE Hospital, Banjara Hills,Road # om Dr. A.K. Omar Escorts Heart Institute Escorts Heart Institute page 2 / 6

3 Dr. Rajeeve Kumar Rajput Dr. K.C. Chockalingam and Research Centre Indraprastha Apollo Hospital Kovai Medical Centre and Hospital Limited, Coimbatore and Research Centre Ltd,Okhla Main Road New Delhi DELHI Indraprastha Apollo Hospital,Sarita Vihar, Delhi-Mathura Road New Delhi DELHI Kovai Medical Centre and Hospital Limited,Post Box No 3209, Avanashi Road Coimbatore TAMIL NADU Dr. Sameer Dani Life Care Hospital Lifecare Institute of Medical Sciences & Research, Sardar Patel Statue corner, Sardar Patel Stadium Road Dr. Prakash V.S. M.S. Ramaiah Memorial Hospital, Dr. Latchumanadhas K. Madras Medical Mission Dr. Lanka Krishna Dr. Jagdish Hiremath Dr. Jayanarayan Naik Dr. Raja Babu Panwar Nizams Institute of Medical Sciences, Hyderabad Poona Hospital & Research Centre, Pune Rabindranath Tagore International Institute of Cardiac Sciences S.P. Medical College & A.G. Hospital, Bikaner M.S. Ramaiah Medical College and Teaching Hospital,MSR Nagar, MSRIT Post KARNATAKA Madras Medical Mission, 4-A,J.J. Nagar Nizams Institute if Medical Sciences, Poona Hospital & Research Centre,27 Sadashiv Peth-30 Pune MAHARASHTRA Rabindranath Tagore International Institute of Cardiac Sciences,124 Mukundapur, E.M.Bypass Kolkata WEST BENGAL S.P. Medical College & A.G. Hospital, Bikaner RAJASTHAN m l.com om m n net com page 3 / 6

4 Details of Ethics Regulatory Clearance Dr. Jugal Bihari Gupta Dr. Aniruddha Dharmadhikari Dr. Gurappa Shetty Gojanur S.R. Kalla Memorial Gastro & General Hospital Shree Saibaba Heart Institute and Research Centre, C/O Suman Hospitals, Nasik St. Johns Medical College and Hospital, 78, Duleshwar Garden, Behind HSBC Bank,Sardar Patel Marg. C-Scheme Op. Mahamarh Bus Stand, Mumbai MAHARASHTRA St Johns Medical College & Hospital,Sarjapur Road KARNATAKA m com of Approval Status Date of Approval Is Independent Ethics? Ethics S.R. Kalla Memorial Ethical for Human Research Clinical Trial Ethics - Bhatia Hospital RTIICS Ethics The Independent Ethics Ethics on Clinical Trials Ethics Institutional Ethics LIMSAR Ethics COmmittee Ethics KMCH Ethics Ethics Ethical Review Board Institutional Review Board Institutional Ethical Review Board Manavta Clinical Research (MCRI) Professional Ethics Instutitional Ethics Institutional Ethics page 4 / 6

5 Status from DCGI Status Date Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Approved/Obtained Health Type No Date Specified Condition hyponatremia Type Details Intervention Lixivaptan mg QD or BID for 60 days Comparator Agent Placebo Placebo comparator Age From Age To Gender Details Day(s) Day(s) Both Inclusion Criteria 1. Men and Women with age greater than or equal to 18 years. 2. Baseline serum sodium comcentration less than 135mEq/L. 3. Current hospitalization for worsening of chronic CHF. 4. The patient has clinical evidence of volume overload. 5. The patient has a documented left ventricular ejection fraction (LVEF) within the past year. 6. Supine systolic arterial blood pressure greater than or equal to 90mmHg. Exclusion Criteria Method of Generating Random Sequence Method of Concealment Exclusion Criteria Details 1. Previous participation in this or any other Lixivaptan clinical trial. 2. Participation in any other investigational study within 30 days prior to screening. 3. Women who will not adhere to the reproductive precautions as outlined in the protocol and in the informed consent. 4. Positive urine pregnancy test. 5. Inability to provide informed consent. 6. Inability to respond to thirst. 7. Inability to take oral medications. 8. Acute severe hyponatremia. 9. Overt symptoms of hyponatremia requiring immediate medical intervention. 10. Hemodynamically significant uncorrected primary cardiac valvular disease. 11. Hypertrophic cardiomyopathy. 12. CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy. 13. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator. 14. ST-segment elevation myocardial infarction within 30 days or active myocardial ischemia at the time of enrollment. 15. History of stroke within 30 days prior to screening. 16. History of cardiac revascularization procedure within 30 days prior to screening. 17. Patients who are on cardiac mechanical support. 18. History of bi-ventricular pacer placement within the last 30 days. 19. Planned revascularization procedures, electrophysiologic device implantation, cardiac support implantation, ultrafiltration or dialysis, or other cardiac surgery within 30 days following study enrollment. 20. Serum creatinine greater than 3.0 mg/dl/265.2mol/l. 21. Uncontrolled diabetes mellitus as defined by the investigator (eg. HbA1c > 9%). 22. Adrenal insufficiency, whether treated or not. 23. History of primary significant liver disease or acute hepatic failure, as defined by the investigator. 24. History of chronic drug/medication abuse within 6 months; or current alcohol abuse. 25. Co-morbid condition with an expected survival of less than 6 months. Computer generated randomization Centralized page 5 / 6

6 Powered by TCPDF ( PDF of Trial Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints The change from baseline in serum sodium concentrations at day 7 of the double-blind, on-therapy period for hyponatremic patients with serum sodium less than 135mEq/L at baseline. Day 7, 14, 28, 42, 60 and followup 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 1. The average daily AUC of change from baseline in serum sodium concentrations. The change from baseline in the recorded time to complete the Trail Making Test, Part B Percentage of patients with worsening hyponatremia during the double-blind, on-therapy period. Percentage of patients with normalized serum sodium concentration (>135 meq/l) Days alive and out of the hospital Total Sample Size=650 Sample Size from =65 08/02/ /02/2008 Years=2 Months=0 Days=0 Closed to Recruitment of Participants Closed to Recruitment of Participants None 1. Up to Day 60 At Day 28 Up to Day 60 At Day 60 Up to 60 days This is a global trial, which will enroll a total of approximately 650 patients worldwide. This trial began enrollment in February 2008, with the plan of enrolling approximately 100 patients in. The overall objective of this study is to determine if lixivaptan is a safe and effective agent for achieving and maintaining increased serum sodium concentrations for the treatment of hyponatremia associated with worsening heart failure. page 6 / 6