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1 Clinical Trial Details (PDF Generation Date :- Sat, 10 Nov :16:52 GMT) CTRI Nuber CTRI/2009/091/ [Registered on: 10/08/2009] - Last Modified On 16/12/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Single Ar Trial A clinical trial to study the effect of conivaptan hydrochloride in patients with Euvoleic and Hypervoleic hyponatreia (a condition where the level of a cheical ion in blood goes below the noral levels) Efficacy and Safety of Intravenous Adinistration of Conivaptan Hydrochloride in the Treatent of Euvoleic and Hypervoleic Hyponatreia - A ulticentric, open label, non coparative, phase III study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) R1CONIV073021, version 3 dated Nae Designation Affiliation Protocol Nuber Details of Principal Investigator Ait Nasa Project Leader Eployee Address Ranbaxy Laboratories Ltd. Plot No. 77-B, Sector 18 Gurgaon HARYANA India Phone Fax Eail Nae Designation Affiliation ait.nasa@ranbaxy.co Details Contact Person (Scientific Query) Dr Sanjay K Shara Associate Director Ranbaxy Laboratories Ltd. Address Medical Monitor, Ranbaxy Laboratories Ltd. Plot No. 77-B, Sector 18 Gurgaon HARYANA India Phone Fax Eail Nae Designation Affiliation SanjayK.Shara2@ranbaxy.co Details Contact Person (Public Query) Ait Nasa Project Leader Eployee Address Ranbaxy Laboratories Ltd. Plot No. 77-B, Sector 18 Gurgaon HARYANA India Phone page 1 / 8

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Fax Eail Source of Monetary or Material Support > Ranbaxy Laboratories Ltd. 77B, IFFCO road, Sector 18, Gurgaon Nae Priary Sponsor Details Ranbaxy Laboratories Liited Address Plot No. 20, Sector 18 Udyog Vihar Industrial Area Gurgaon Haryana INDIA Type of Sponsor Nae NIL List of Countries India Nae of Principal Investigator Dr. Narendra M. Bhabure Dr. Hussaini Shaista Dr. Suhas Erande Pharaceutical industry-global Address Nae of Site Site Address Phone/Fax/Eail ICU-Incharge, Maharastra Medical Foundation Joshi Hospital,778 Shivaji Nagar, Pune "CARE Hospital, Napally, Hyderabad Akshay Hospital, Opp. SNDT College, Karve Road, Pune Dr Raghunath Aldakatti Apollo BGS Hospital,Adichunchun giri Road,Kuvepu Nagar,Mysore Dr. Navjot Singh Dr. V.S. Desai Associate Professor, Departent of Medicine, Christian Medical College, Ludhiana Belgau Lifeline Intensive Care Center Pvt. Ltd, Jeevan Rekha, Belgau ICU Incharge, Maharastra Medical Foundation Joshi Hospital,,778Shivaji Nagar,Oppo. Kaala Nehru Park, Erandwane Pune CARE Hospital,,Napal ly Hyderabad ANDHRA PRADESH Consultant Physician, Akshay Hospital,Opp. SNDT College, Karve Road Pune Apollo BGS Hospital,Adichunchun giri Road,Kuvepu Nagar Mysore KARNATAKA Associate Professor, Departent of Medicine, Christian Medical College Ludhiana PUNJAB Physician and Cardiologist,Belgau Lifeline Intensive Care Center Pvt. Ltd,Jeevan Rekha Belgau KARNATAKA il.co co.in l.co , page 2 / 8

3 Dr.Mukesh Jain Dr. Rajashree Sanjay Khot Dr Padaraj Hegde Dr. Vidya Kada Dr. Jayesh Tiane Dr. C. Rajendran Dr. Gopal Raval Dr. Tarun Kuar Saha Dr. Nilia Sudhakar Bhalerao Consultant Physician Consultant Physician Tagore Hospital and Tagore Hospital and Research Center, Research Center Tagore Lane, Mansarov,Tagore Lane, ar,jaipur Mansarovar Jaipur RAJASTHAN Departent of Medicine, Govt. Medical College, Hanuan Nagar, Nagpur Departent of Urology, Kasturba Medical College Hospital, Manipal Dr. L.H Hiranandani Hospital, Hill side Avenue, Hiranandani Gardens, Powai, Mubai Getwell Hospital & Research Institute, Khare Marg, Dhantoli, Nagpur Governent General Hospital, Intensive Medical Care Unit, Chennai Associate Professor, Departent of Medicine, Govt. Medical College,Hanuan Nagar Nagpur Professor and Head, Departent of Urology,Kasturba Medical College Hospital Udupi KARNATAKA Dr. L.H Hiranandani Hospital, Hill side Avenue,,Hiranandani Gardens, Powai, Mubai Getwell Hospital & Research Institute,Khare Marg, Dhantoli, Nagpur HCG Medisurge Consultant Hospital, Near Mithakali Six Roads, Ellisbridge, Ahedabad Kaineni Hospitals, LB Nagar, Hyderabad King Edward (KEM) Hospital, Sardar Chief Intensive Care Medical Unit,Governent General Hospital,Intensive Medical Care Unit Chennai TAMIL NADU Pulonologist and Critical Care Specialist, HCG Medisurge Hospital,Near Mithakali Six Roads, Ellisbridge Ahadabad GUJARAT Consultant and Head Nephrology, Kaineni Hospitals,LB Nagar Hyderabad ANDHRA PRADESH Associate Consultant Neurologist, King , o hegdepadaraj@hot ail.co vidya_kada@hotail. co jayeshtiane@yahoo.c o , dr.crajendiran@gail.c o , raval_g@yahoo.co , drtksaha@rediffail.co page 3 / 8

4 Details of Ethics Coittee Dr NP Singh Dr. Nilay N. Suthar Dr. A Raesh Jawahirani Dr. Rajeev Sood Moodliar Road, Rasta Peth,Pune Edward (KEM) Hospital,Sardar Moodliar Road, Rasta Peth Pune Prof. Depart. of Internal Professor, Departent Medicine Maulana Azad of Internal Medical College Medicine,MAMC and Lok Nayak Hospital, Bahadur Shah Zafar Marg,New Delhi New Delhi DELHI Sheth V.S. Hospital, Ellisbridge, Ahedabad Shri Krishna Hrudalaya, Congress Nagar Square, Nagpur Sr. Urologist and Associate Prof & Head-Urology, Dr. Ra Manohar Lohia Hospital & PGIMER, New Delhi Dr. E. Dhandapani Stanley Hospital #8, Old Jail Road,Parrys, Near Bharathi Arts College,Chennai Dr. Revathi Aiyer Sterling Hospital, Race Course Circle (West) Vadodara Assistant Professor of Medicine, Sheth V.S. H ospital,ellisbridge Ahadabad GUJARAT Consultant Cardiologist, Shri Krishna Hrudalaya,Congress Nagar Square Nagpur Roo No. 31 Ground Floor, OPD Building, Baba Kharak Singh Marg, Dr. Ra Manohar Lohia Hospital & PGIMER, New Delhi New Delhi DELHI Chief IMCU, Stanley Hospital #8, Old Jail Road,Parrys, Near Bharathi Arts College Chennai TAMIL NADU ICU Physician, Sterling Hospital,Race Course Circle (West) Vadodara GUJARAT iabhalerao@gail.c o NIL nanu_singh@yahoo.co ay_suthar@yahoo.co araesh123@rediff ail.co , drsoodr@yahoo.co , dhanduhariguru@hot ail.co , revathiaiyer@gail.co Nae of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? Citizens Non-Instituional Independent Ethics Coittee, Pune Clinico Independent Ethics Coittee, Bangalore Approved 11/04/2009 Yes Approved 19/03/2009 Yes Dr. Ra Manohar Lohia Approved 12/08/2009 No page 4 / 8

5 Hospital & PGIMER Ethics Coittee, New Delhi Getwell Independent Ethics Coittee, Nagpur HCG Medisurge Hospital,Ethics Coittee, Ahedabad Coittee Christian Medical College, Ludhiana Coittee Stanley Medical College, Chennai Approved 24/04/2009 Yes Approved 30/05/2009 No Approved 23/09/2009 No Approved 17/07/2009 No Approved 30/09/2009 No Coittee, Apollo BGS Hospital Mysore Coittee, CARE Hospital, Hyderabad Approved 02/11/2008 No Approved 15/04/2009 No Coittee, Govt. Medical College Nagpur Coittee, Kaineni Hospitals, Hyderabad Coittee, Kasturba Medical College, Manipal Approved 31/10/2008 No Approved 14/04/2009 No Coittee, MAMC Society for prootion of Medical Research, New Delhi Approved 22/09/2009 No L.H.Hiranandani Hospital Ethics Coittee, Mubai Maharashtra Medical Research Society, Pune Research Institute/Center, King Edward Meorial Hospital, Pune. Sheth V.S. Hospital Medical Research Foundation Trust, Ahedabad Sterling Hospital Ethics Coittee, Ahedabad Approved 19/08/2009 No Approved 25/09/2009 No Approved 09/01/2009 No Approved 12/03/2009 No Approved 14/07/2009 No Swasthya Kalyan Ethics Approved 16/09/2009 Yes page 5 / 8

6 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Intervention / Coparator Agent Inclusion Criteria Coittee, Jaipur The Ethical Coittee of Govt.General Hospital, Chennai Status Approved 12/06/2009 No Date Approved/Obtained 16/12/2008 Health Type Patients Condition Euvoleic and Hypervoleic Hyponatreia Type Nae Details Intervention Conivaptan Hydrochloride Loading dose: 20 g over 30 in (Assessent 2) Continuous infusion: 20 g over 24 hrs (Assessent 2-5) Coparator Agent NIL NIL Age Fro Age To Gender Details Month(s) Year(s) Both Inclusion Criteria 1.Patients of either sex, aged ore than or equal to 18 years. 2.Patients who have ean seru sodiu concentration between 115 and 129 Eq per liter both inclusive. 3.Patients who have seru osolality less 290 Osol per kg water. Exclusion Criteria Details Mean seru sodiu concentration refers to the ean of two seru sodiu readings 0 and 4 hours obtained during the baseline period of 4 to 12 hours. For the patients in who treatent of hyponatreia with conivaptan cannot be delayed, the saple at 0 hr will be considered as the baseline reading. Note: Patients of either sex, aged ore than or equal to 18 years Exclusion Criteria 1.Patients unwilling or unable to give infored consent. 2.Rando blood glucose ore than or equal to 300 g per dl. 3.Urinary sodiu less tha 30Eq per liter with noral dietary salt intake. 4.Patients expected to have hyponatreia necessitating eergent treatent during the study. 5.Patients diagnosed with hypovoleic hyponatreia. 6.Patients diagnosed with congestive heart failure CHF NYHA class IV or Cirrhosis 7.Pregnant or lactating woen or woen in reproductive age group not using reliable contraception i.e. a edically accepted effective ethod of birth control 8.Patients with cardiac surgery, yocardial infarction, unstable angina or cerebrovascular accident in the past 3 onths. 9.Patients with uncontrolled hypertension or supine systolic blood pressure less than 85 Hg. 10.Patients with uncontrolled arrhythias 11.Patients with creatinine clearance less than or equal to 30 l per in per Patients with urinary outflow obstruction unless catheterized. 13.Patients with abnoral laboratory values at adission into the study: SGOT or SGPT ore than 3 ties the upper liit of noral or seru albuin less than or equal to 1.5 g/dl. 14.Prothrobin tie greater than 22 sec or an international page 6 / 8

7 noralized ratio greater than 2.0 without anticoagulant therapy or 3.0 or ore with therapy. 15.Patients taking CYP3A4 inhibitors or substrates such as ketoconazole, itraconazole, clarithroycin, ritonavir, indinavir, calciu channel blockers, digoxin or digitoxin, statins, benzodiazepines, vasopressin, oxytocin, desopressin, carbaazepine, lithiu, deeclocycline and urea. 16.Patients in who another investigational drug defined as not approved for any indication by the local regulatory agency was used within 30 days of screening 17.Patients with any concurrent illness that could interfere with study treatent or its evaluation. Method of Generating Rando Sequence Method of Concealent Blinding/Masking Not Applicable Not Applicable Not Applicable Priary Outcoe Outcoe Tiepoints Mean change in the seru sodiu level fro Seru Sodiu baseline to end of study Clinical significance Assessent 1 0 and 4 hr Mean change in seru sodiu level ore than 4 Assessent 2 to 5 Morning and Evening Eq per L Baseline seru sodiu concentration refers to the ean of two seru sodiu readings 0 and 4 hours obtained during the baseline period of 4 to 12 hours For the patients in who treatent of hyponatreia with conivaptan cannot be delayed the saple at 0 hr will be considered as the baseline reading Secondary Outcoe Outcoe Tiepoints Target Saple Size Phase of Trial Phase 3 Date of First Enrollent (India) Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial (India) Publication Details Percentage of patients with a ore than 6Eq Seru Sodiu Assessent 1 0 and 4 hr per L increase fro baseline in seru sodiu Assessent 2 to 5 Morning and Evening concentration or an increase to a noral seru sodiu ore than 135Eq per L level Baseline seru sodiu concentration refers to the ean of two seru sodiu readings 0 and 4 hours obtained during the baseline period of 4 to 12 hours. For the patients in who treatent of hyponatreia with conivaptan cannot be delayed, the saple at 0 hr will be considered as the baseline reading Total Saple Size=75 Saple Size fro India=75 30/03/2009 No Date Specified Years=0 Months=9 Days=0 Not Applicable Copleted None page 7 / 8

8 Powered by TCPDF ( PDF of Trial Brief Suary This study is a ulticentric, open label, non coparative, phase III study with a objective to assess the efficacy and safety of Conivaptan hydrochloride injection (adinistered as a loading dose of 20 g for 30 in followed by the continuous intravenous of 20 g for 24 hrs at assessent 2 and further based on the seru sodiu readings adinistration of drug will be given as continuous intravenous infusion of 20 or 40 g per day for an additional 1-3 days) in the treatent of euvoleic and hypervoleic hyponatreia. We have updated list of investigators, ethics coittee approval status for version 3, inclusion and exclusion criteria, priary and secondary outcoe page 8 / 8