Clinical Trial Details (PDF Generation Date :- Sun, 31 Mar 2019 14:01:04 GMT) CTRI Number Last Modified On 11/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/01/005359 [Registered on: 06/01/2015] - Trial Registered Prospectively No Interventional Drug Other Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension A Multicentric, Prospective, Double blind, Randomized, Comparative Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension 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) ZUV/CARD/EFON/04/2011 Version No 1 Date 7th May 2013 Designation Affiliation Phone Fax Email Designation Affiliation Phone Fax Email Designation Affiliation Protocol Number Details of Principal Investigator Dr Girish Rajadhyaksha Principle Inestigator B. Y. L. Nair Charitable Hospital Department of Medicine, 104 College Building, B. Y. L. Nair Charitable Hospital Mumbai- Mumbai 400008 girishraj63@gmail.com Details Contact Person (Scientific Query) Dr Bhupesh Dewan Director Medical Services Zuventus Healthcare Ltd Office no 5119 D wing 5th floor Oberoi Garden Estates Chandivali Andheri east Mumbai (Suburban) 400072 bhupesh.dewan@zuventus.com Details Contact Person (Public Query) Dr Bhupesh Dewan Director Medical Services Zuventus Healthcare Ltd Office no 5119 D wing 5th floor Oberoi Garden Estates Chandivali Andheri east Mumbai (Suburban) 400072 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Email > Zuventus Healthcare Ltd Type of Sponsor NIL List of Countries of Principal Investigator bhupesh.dewan@zuventus.com Source of Monetary or Material Support Primary Sponsor Details Zuventus Healthcare Ltd Office no 5119 D wing 5th Floor Oberoi Garden Estates Chandivali Andheri East Pharmaceutical industry-n Dr Girish Rajadhyaksha B. Y. L. Nair Charitable Hospital Dr Nakul Sinha Dr Mrunalini Motlag Dr Gouranga Sarkar Dr Srinivas Reddy NIL of Site Site Phone/Fax/Email Divine Heart and Multispeciality Hospital, Indira Gandhi Government Medical College and Hospital Institute of Post Graduate Medical Education & Research, Kolkata King George Hospital Andhra Medical College, Visakhapatnam Department of medicine B. Y. L. Nair Charitable Hospital Mumbai-400008 Mumbai 9821695349 girishraj63@gmail.com Divine Heart and 9919002760 Multispeciality Hospital, Viraj Khand Institutional sinha.nakul@gmail.com Area - 5, Gomti Nagar,, Uttar Pradesh 226010 UTTAR PRADESH Department of medicine Indira Gandhi Government Medical College and Hospital, Nagpur Nagpur Institute of Post Graduate Medical Education & Research 244, AJ.C. Bose Road, Kolkata- 700020. Kolkata WEST BENGAL Department of Medicine, King George Hospital, Andhra Visakhapatnam-530002, Andhra Pradesh,. Visakhapatnam 9960031486 drvandanabadar@yaho o.co.in 9830165760 drgsmed@gmail.com 9703157774 bioexperts21@gmail.co m Dr Jitendra Kodilkar MVP Samajs Dr. MVP Samajs Dr. 9890314681 page 2 / 6
Details of Ethics Dr Akula Siva Prasad Dr Sanjay Sharma Dr BLN Prasad Dr Aditya Kapoor Dr Atul Patil Vasantrao Pawar Hospital & Research Centre Nizam Institute of Omega Hospital, Mangalore Rajiv Gandhi Institute of Sanjay Gandhi Post Graduate Institute of Shree Saibaba Heart Institute and Research Centre, Nashik Vasantrao Pawar Hospital & Research Centre, department of medicine, Adgao, Nasik Nashik Panjagutta. Landmark Near GVK Mall Punjagutta, Hyderabad Andhra Pradesh, 500082 Hyderabad Omega Hospital, Kankanady Bypass Road, Mahaveera Circle, Kankanady, Mangaluru, Karnataka 575002 Dakshina Kannada KARNATAKA Rajiv Gandhi Institute of Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001 Srikakulam Department of Cardiology Sanjay Gandhi Post Graduate Institute of Medical Sciences UTTAR PRADESH Shree Saibaba Heart Institute and Research Center, Near Kalidas Kala Mandir,Shalimar, Nashik Nashik Dr Sharath Annam Sunshine Hospital Department of Cardiology Behind Paradise Hotel,Penderghast Road, Opposite Parsi Dharamsala, Secunder abad,pin-500003 Hyderabad jitendrakodilkar@gmail. com 9989732529 akulasivaprasad@gmail.com 9910335590 sanju078@yahoo.co.uk 9848211931 amcmedicine@hotmail. com 5222668079 akapoor65@gmail.com 7507305533 dratpatil@gmail.com 91040646363 cardogh@gmail.com of Approval Status Date of Approval Is Independent Ethics? Dr. Vasantrao Pawar Hospital & Research Approved 05/09/2015 No page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Centre Indira Gandhi Hospital of Topiwala National Medical College and B.Y.L.Nair Charitable Hospital Sanjay Gandhi Hospital Sunshine Hospital, Divine Heart and Multispeciality Hospital,, King George Hospital, NIMS, RIMS IPGME and R Research Oversight Omega Ethics Shree Saibaba Ethics Status Submittted/Under Review No Date Specified No Approved 23/02/2015 No Submittted/Under Review No Date Specified No Approved 12/02/2014 No Approved 26/03/2016 No Approved 29/09/2014 No Approved 10/01/2015 No Approved 07/10/2014 No Approved 23/05/2015 No Approved 03/10/2014 No Approved 11/04/2015 No Date Approved/Obtained 20/01/2014 Health Type Patients Condition patients with Hypertension Type Details Intervention Efonidipine Efonidipine 40 mg orally o.d. for 4 weeks Comparator Agent Amlodipine Amlodipine 5 mg orally o.d. for 4 weeks Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 1.Patients aged 18 to 65 years 2.Patients with stage 1 hypertension as per Joint National on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII) 3.Patients with heart rate > 83 beats/min 4.Patients ready to sign informed consent page 4 / 6
Exclusion Criteria Exclusion Criteria Details 1.Patients with severe hypertension with sitting systolic BP? 180 mm Hg 2.Patients with history of stroke or myocardial infarction in the previous 6 months 3.Patients with congestive heart failure, sick sinus syndrome or sinus bradycardia (4.Patients with second- or third-degree atrioventricular block 5.Patients with documented hypersensitivity to dihydropyridine CCBs 6.Patients with hepatic disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper normal limit 7.Patients with renal disease with a serum creatinine concentration > 2.0 mg/dl 8.Patients with uncontrolled diabetes, (hemoglobin A1C > 9%), renal artery stenosis, or secondary hypertension 9.Pregnant women or nursing mothers 10.Females with child bearing potential (considerations relate to choice of contraception, planning for pregnancy and overall obstetric care during pregnancy) 11.Patients with history of alcohol dependence, alcohol abuse or drug abuse 12.Patients with history of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) 13.Patients scheduled for surgery anytime during the study 14.Patient receiving some other drug during the study besides that in the protocol that could possibly alter the bio availability of the drug 15.The patient previously been participated in any other clinical trial within the last month Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Double Blind Double Dummy Primary Outcome Outcome Timepoints Proportion of patients achieving JNC VII target BP of 140/90 mm Hg by the end of treatment Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study) Secondary Outcome Outcome Timepoints Proportion of patients achieving JNC VII target BP of 140/90 mm Hg after 2 weeks of therapy Proportion of patients achieving heart rate 83 beats per minute after 2 weeks of therapy Symptom relief: Defined as the absence of the clinical symptom of dyspnea and palpitations after 4 weeks of therapy Target Sample Size Adverse events observed during the treatment period Total Sample Size=200 Sample Size from =200 page 5 / 6
Powered by TCPDF (www.tcpdf.org) 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 30/01/2015 No Date Specified Years=1 Months=0 Days=0 Not Applicable Open to Recruitment A Multicentric, Prospective, Double blind, Randomized, Comparative Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension The aim of the study is to establish non-inferiority of Efonidipine hydrochloride when compared with Amlodipine in the management of hypertension Primary Objective To assess the efficacy of Efonidipine 40 mg given once a day orally in alleviating symptoms of hypertension Secondary Objective To evaluate the safety & tolerability of the investigational drug in n patients. To evaluate patient compliance page 6 / 6