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1 Clinical Trial Details (PDF Generation Date :- Sat, 24 Nov :16:02 GMT) CTRI Number CTRI/2010/091/ [Registered on: 05/08/2010] - Last Modified On 01/03/2013 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, Active Controlled Trial A phase 3 clinical trial to study the efficacy and safety of drug fasudil in comparison with nimodipine in patients with non-traumatic subarachnoid hemorrhage An open label, randomized, parallel group, prospective, multicentre clinical trial for evaluation of efficacy and safety of fasudil hydrochloride in comparison with nimodipine following non-traumatic subarachnoid hemorrhage 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) CT/ FSDL/SAH/PHASE III/10 Designation Affiliation DCGI Details of Principal Investigator Dr Rajendra C Rane Sr Vice President Intas Pharma Phone Fax Designation Affiliation Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad rane@intaspharma.com Details Contact Person (Scientific Query) Dr Kanhei Charan Sahoo Medical adviser Intas Pharma Phone Fax Designation Affiliation Medical Services Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road Kanheicharan_sahoo@intaspharma.com Details Contact Person (Public Query) Dr Dimple Shah Medical adviser Intas Pharma Medical Services Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Intas Pharmaceuticals Limited, Ahmedabad Type of Sponsor Nil List of Countries of Principal Investigator Dr. Sumit Sinha Dr. Rajendra Kabaria Source of Monetary or Material Support Primary Sponsor Details Intas Pharmaceuticals Limited Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road Pharmaceutical industry-n of Site Site Phone/Fax/ All Institute of Medical Sciences (AIIMS) Ashirwad Nursing Home Assistant Professor, Jai Prakash Narayan Apex Trauma Centre,,Department of Neurosurgery, All Institute of Medical Sciences (AIIMS), Ashirwad Nursing Home,,Near Adarsh Complex, Jail Road, Bhavnagar Dr. Nitin Sampat Bhatia Hospital Bhatia Hospital,Tardeo Road Mumbai Dr. Rahul Kulkarni Deenanath Mangeshkar Hospital Consulting Neurologist, Deenanath Mangeshkar Hospital & Research Centre,,Erandawane Pune Dr. C K Pakmode Getwell hospital Getwell hospital, 20/1, Khare Marg,,Behind Vijayanand Society, - Dr. Nasli.R. Ichaporia Jehangir Hospital Jehangir Clinical Development Centre Pvt. Ltd.,,Jehangir Hospital Premises, 32 Sassoon Road, ; ; sumitaiims@yahoo.com ; sumitneuro@gmail.com ; rajendrakabaria@yahoo.com , nitinsampat@hotmail.co m , / rahulneuro@vsnl.net ; drcspakmode@rediffma il.com page 2 / 6

3 Details of Ethics Committee Dr. Agasti Krishna Reddy Dr Umesh Kalra Dr. Ramesh Madhav Patankar Dr. Manish A. Rathi Dr. C.S. Agarwal Krishna Institue of Medical Sciences Sarvodaya Multispeciality Hospital Shree Hospital 001 Pune Chief Neurosurgeon, Krishna Institue of Medical Sciences,,#1-8-31/1, Minister Road Sarvodaya Multispeciality Hospital Opp Red Cross Bhawan Delhi Road Hisar HARYANA Shree Hospital, Near Geeta Bhawan,,Near Chembur Station, Chembur (E), Mumbai Siddhi Vinayak Hospital Siddhi Vinayak Hospital, Bal Vatika,Maninagar Road, Kankaria Sir Ganga Ram Hospital , ; m om , / / o.co.in ; / / n Senior consultant and , chairman, Department , of Neurology,,Sir /55 Ganga Ram Hospital, Rajinder Nagar, New Delhi DELHI Dr. Parimal Tripathi Sterling Hospital Sterling Hospital,,Sterling Hospital Road, Memnagar, Dr. Sameer Paltewar Suretech Hospital and Research Centre Suretech Hospital and Research Centre,,13-A, Banerjee Marg, Dr. Nirmal Surya Surya Neuro Centre Surya Neuro Centre 310, Lotus House,,33/A, New Marine Lines, Next to liberty Cinema, Mumbai , ; / / / m , / om ; suryaneuro@hath way.com of Committee Approval Status Date of Approval Is Committee? page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr. Nirmal Surya Dr. Rajendra Kabaria Dr. Ramesh Madhav Patankar Dr. Umesh Kalra Committee, Bhatia Hospital, Mumbai for Dr. Nitin Sampat Committee, Deenanath Mangeshkar Hospital and Research Centre, Pune for Dr. Rahul Kulkarni Approved 25/06/2010 No Approved 14/10/2010 No Committee, KIMS Hospital, Secunderabad for Dr. Agasti Krishna Reddy Approved 25/05/2010 No Committee, Sir Ganga Ram Hospital, New Delhi for Dr. C.S. Agarwal Sterling Hospital Ethics Committee, Ahmedabad for Dr. Parimal Tripathi Status Approved 18/01/2011 No Approved 23/08/2010 No Date Approved/Obtained 23/07/2010 Health Type Patients Condition Non-traumatic subarachnoid hemorrhage Type Details Intervention Comparator Agent Fasudil hydrochloride injection 30 mg/2 ml Nimodipine injection 10 mg/50 ml Inclusion Criteria 1 ampoule to be dissolved in 100 ml normal saline administered as intravenous slow infusion (over 30 minutes) every 8 hourly for 14 days Intravenously: for the first two hours about 15 microgram/kg bw/h, may be increased to 30 microgram/kg bw/h; Patients of body weight less than 70 kg or with unstable blood pressure should be started 7.5 microgram/kg bw/h; co-infusion with intravenous fluids 40 ml/hour page 4 / 6

5 Age From Age To Gender Details Year(s) Year(s) Both 1)Either sex, age between 18 and 70 years hospitalized with non-traumatic SAH (subarachnoid hemorrhage) 2)In case of females with child bearing potential, negative serum pregnancy test at screening and willing to use medically acceptable contraceptive through out the study period 3)Himself/herself or his/her legally accepted representative willing to provide written informed consent 4)For whom study medication can be started within 56 hours of detection of SAH Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Open Label Exclusion Criteria 1)Recent history of stroke or subarachnoid hemorrhage 2)Patients with hypotension (systolic blood pressure (SBP) < or = 90 mm Hg) at baseline 3)Patient with serious disturbance of consciousness, patient with subarachnoid hemorrhage combined with serious cerebrovascular damage 4)Patients with presence of cerebral edema and severely raised intracranial pressure at screening 5)Ongoing lactation 6)Patients with pulmonary edema or severe cardiac failure requiring inotropic support at the time of randomization 7)Hepatic function impairment (SGPT or SGOT level > or = 2.5 times upper normal limit) or renal function impairment (serum creatinine > or = 1.5 times upper normal limit) 8)Ongoing use of prohibited medications? vasodilators, nephrotoxic drugs, inhibitors of CYP 3A4, intravenous beta blockers 9)As deemed inappropriate for enrollment by investigating physician due to other reasons Primary Outcome Outcome Timepoints Delayed Ischemic Neurological Deficits During two weeks of treatment period Secondary Outcome Outcome Timepoints 1) Neurological worsening 2) Requirement of administration of a valid rescue therapy 3) 3 or score of Modified Rankin Scale 1) During two weeks of treatment period 2) During two weeks of treatment period 3) At the end of study 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 Total Sample Size=200 Sample Size from =200 03/08/ /08/2010 Years=1 Months=0 Days=0 Suspended page 5 / 6

6 Powered by TCPDF ( PDF of Trial Trial () Publication Details Brief Summary Nil To compare the efficacy and safety of fasudil with nimodipine in adult patients hospitalized with non-traumatic SAH. Cerebral vasospasm constitutes a major complication of subarachnoid hemorrhage. Percentage of patients developing DIND (Delayed Ischemic Neurological Deficits) due to vasospasm during study medication period (defined by low density lesion on CT scan associated with neurological worsening) in each group would be considered as primary outcome. The other efficacy parameters include neurological worsening (defined as a decline of at least 2 points in the Glasgow Coma Scale or an increase of at least 2 points in the abbreviated National Institutes of Health Stroke Scale), administration of rescue therapy for DIND and modified Rankin Scale (mrs) for residual disability at the end of the study. The hemodynamic therapy (Tiple H therapy) or angioplasty will be allowed as rescue therapy. The trial will be conducted in n patients only and within only. Anticipated date for first patient enrolment in the study is page 6 / 6