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CTRI Number  CTRI/2017/08/009242 [Registered on: 03/08/2017] Trial Registered Prospectively
Last Modified On: 24/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate the Efficacy, Safety of Fimasartan Tablets Vs Losartan Tablets in Patients with Mild Essential Hypertension. 
Scientific Title of Study   A Comparative, Randomized, Double Blind, Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan Tablets Vs. Losartan Tablets in Patients with Mild Essential Hypertension 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
APL/CT/15/03  Protocol Number 
Version No. 01, Jun 06, 2016  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gurusaran Sidhu 
Designation  Principal Investigator 
Affiliation  Sidhu Hospital Pvt 
Address  Sidhu Hospital Pvt. Ltd., G.T. Road, Doraha-141421. Ludhiana. Punjab.

Ludhiana
PUNJAB
141421
India 
Phone  9876177701  
Fax    
Email  gursaransidhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh Singh 
Designation  Sr. Vice President R&D and Reg. Affairs  
Affiliation  Ajanta Pharma Ltd 
Address  Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.

Mumbai
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh Singh 
Designation  Sr. Vice President R&D and Reg. Affairs  
Affiliation  Ajanta Pharma Ltd 
Address  Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.

Mumbai
MAHARASHTRA
400067
India 
Phone  2266062111  
Fax    
Email  shailesh.singh@ajantapharma.com  
 
Source of Monetary or Material Support  
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA. Mumbai MAHARASHTRA 400067. 
 
Primary Sponsor  
Name  Ajanta Pharma Ltd  
Address  Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA. Mumbai MAHARASHTRA 400067.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 22  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Padmalatha  Andhra Medical College & King George Hospital  Department of Medicine, Maharanipeta Visakhapatnam-530002. Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH 		 9246620072

padmalathamdgen@gmail.com 
Dr Tejas Madhusundan Patel  Apex Heart Institute   Department of Cardiology, Block No: G-K, Mondeal Business Park, Near Gurudwara, S. G. Highway, Ahmedabad-380054. Gujarat.
Ahmadabad
GUJARAT 		 9824030576

tejaspatel@apexheart.in 
Dr Brij Mohan Goyal  Apex Hospital Pvt.Ltd  SP 4 & 6 Malviya industrial area Malviya Nagar
Jaipur
RAJASTHAN 		 9413190570

drbrijmohan.goyal@gmail.com 
Dr Hemant Kokane  B. J. Government Medical College & Sassoon General Hospital  Department of Cardiology, SJai Prakash Narayan Road, Pune – 411001. Maharashtra.
Pune
MAHARASHTRA 		 9619284398

drhemantkokane@gmail.com 
Dr Owais Maskati  B.J. Medical College and Civil Hospital,  Department of Cardiology, Asarwa, Ahmedabad-380016. Gujarat.
Ahmadabad
GUJARAT 		 9825608147

owaismaskati@gmail.com 
Dr Brij Mohan  Brij Medical Centre  94-E, Panki, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 9415043742

drbrijmohan@bmchospital.in 
Dr Sanjeev Kumar Sharma  Eternal Heart Care Centre & Research Institute Pvt. Ltd  Department of Cardiology, 3A, Jagatpura Road, Near Jawahar Circle, Jaipur-302017. Rajasthan.
Jaipur
RAJASTHAN 		 9983333421

sanzsharma@gmail.com 
Dr Anil Kumar  Gandhi Hospital  Department of General Medicine, Musheerabad, Secunderabad 500003
Hyderabad
ANDHRA PRADESH 		 9440523902

anilddrmd@gmail.com 
Dr Rohit Deshpande  Grant Government Medical College and Sir J.J Group of Hospitals  Department of Cardiology, LT Road,Mumbai.
Mumbai
MAHARASHTRA 		 9096050150

coolrohit258@gmail.com 
Dr Saurabh Agarwal  GSVM Medical College  Post Graduate Department of Medicine,GSVM Medical College, Swaroop Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 9415039582

dragarwalsaurabh@gmail.com 
Dr Nishant Tripathy  Indira Gandhi Institute of Medical Sciences  Department of Cardiology, Sheikhpura, Patna-800 014
Patna
BIHAR 		 7011558846

tnishant@yahoo.com 
Dr Prof Dhurjati Prasad Sinha  IPGME&R, SSKM Hospital  Department of Cardiology, 244, Acharya Jagadish Chandra Bose Road, Kolkata-700020. West Bengal.
Kolkata
WEST BENGAL 		 09433018443

drdpsinha@gmail.com 
Dr Suhas N Kalashetti  KEM Hospital Research Center  Department of Cardiology, Sardar Moodilar Road, Rasta Peth, Pune-411011. Maharashtra.
Pune
MAHARASHTRA 		 08805387387

skalashetti@yahoo.co.in 
Dr JTPol  KMRF‟S Nikop Hospital  Department of Cardiology, Ring Road, Phaltan-415 523, Dist. Satara, Maharashtra.
Satara
MAHARASHTRA 		 9822037374

jalindarpol@gmail.com 
Dr Sunil Massand  Maharaja Agrasen Hospital  Department of Cardiology, West Punjabi Bagh, Delhi-110026
New Delhi
DELHI 		 1140777666

sunilmassand@yahoo.com 
Dr Krishna Mala Konda Reddy  Osmania General Hospital,   Department of Cardiology, Afzalgunj, Hyderabad-500012. Telangana.
Hyderabad
ANDHRA PRADESH 		 9848015098

drkmkreddyp@yahoo.com 
Dr A Gopal Rao  Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Department of Medicine,, Shrikakulum -532001, Andhra Pradesh,India
Srikakulam
ANDHRA PRADESH 		 8942279033

rimsresearch@gmail.com 
Dr Devendra Kumar Agarwal  S.P. Medical College & A.G. Hospitals  Department of Cardiology, Bikaner-334003. Rajasthan.
Bikaner
RAJASTHAN 		 1512525451

research_spmc@yahoo.com 
Dr Nitin Kamalakar Ghaisas  Shatabdi Superspecialty Hospital  Department of Cardiology, Suyojit Centre, OPP. Mahamarg Bus Stand, Mumbai Naka, Nashik-422005. Maharashtra.
Nashik
MAHARASHTRA 		 2532593002

nitin.ghaisas@gmail.com 
Dr Gurusaran Sidhu  Sidhu Hospital Pvt. Ltd  Department of Cardiology, G.T. Road, Doraha-141421. Ludhiana. Punjab.
Ludhiana
PUNJAB 		 9876177701

gursaransidhu@gmail.com 
Dr Shrikant Sharma  SMS Medical College & attached Hospitals  Department of Medicine, JLN Marg, Jaipur, Rajasthan
Jaipur
RAJASTHAN 		 9214403945

skant_sunita@yahoo.co.in 
Dr C B Keshavamurthy  Vikram Hospital Pvt. Ltd  Department of Cardiology, # 46, Vivekananda Road, Yadavagiri, Mysore - 570020. Karnataka.
Mysore
KARNATAKA 		 9341052852

cbkeshavamurthy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 22  
Name of Committee  Approval Status 
B.J. Government Medical College, Institutional Ethics Committee  Approved 
Ethic Committee, S.M.S. Medical College & Attached Hospitals  Approved 
Ethics Committee Apex Hospital Private Limited  Approved 
Ethics Committee Brij Medical Center  Approved 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee of Apex Heart Institute  Submittted/Under Review 
Ethics Committee, Eternal Heart Care Centre and Research   Submittted/Under Review 
Ethics Committee, Indira Gandhi Institute of Medical Sciences   Submittted/Under Review 
Ethics Committee, Institutional Review Board, Sidhu Educational Research Institute and Hospital  Approved 
Ethics Committee, King George Hospital  Submittted/Under Review 
Ethics Committee, Osmania Medical College,  Approved 
Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital  Approved 
Ethics Committee, S.P Medical College and A.G Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Gandhi Medical College/Hospital  Approved 
Institutional Ethics Committee, Grant Government. Medical College & Sir JJ Group of Hospital,  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
IPGME&R Research Oversight Committee  Approved 
KEM Hospital Research Centre Ethics Committee  Submittted/Under Review 
KMRF’S Nikop Institutional Ethics Committee  Approved 
Shatabdi Hospital Ethics Committee  Submittted/Under Review 
The Institutional Ethics Committee, B.J. Medical College and Civil Hospital  Approved 
Vikram Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, Mild Essential Hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fimasartan Tablets 60 mg & 120 mg  One Tablet orally once daily in the morning for 90 days 
Comparator Agent  Losartan Tablets 50 mg and 100 mg  One Tablet orally once daily in the morning for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Hypertension with SBP 140 to 159 mmHg and DBP 90 to 99 mmHg
2. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 
 
ExclusionCriteria 
Details  1. Patients diagnosed with Moderate to Severe Hypertension (defined as a SBP ≥160 mmHg and DBP ≥100 mmHg) as defined by 6th report of JNC on Prevention, Detection, Evaluation Treatment of High Blood Pressure.
2. Subjects who are on any other antihypertensive or diuretic drugs.
3. Patients with severe renal impairment (eGFR ≤ 30ml/min).
4. Serum potassium > 5.5 mEq/L or < 3.0 mEq/L at baseline.
5. Patients with hepatic impairment [SGOT, SGPT and S. Bilirubin (total) ≥ 2 times the upper limit of normal reference values].
6. Patients with clinical ASCVD defined as Obstructive coronary artery disease, peripheral vascular disease and Cerebrovascular disease
7. Patients who have undergone Percutaneous Transluminal Coronary Angiography (PTCA), and Coronary Artery Bypass Graft (CABG).
8. Patients with structural heart disease like hypertrophic obstructive cardiomyopathy, hemodynamically significant aortic valve or mitral valve disease, Pericardial diseases & CHF of any etiology.
9. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia.
10. Patient with history of Type I or Type II Diabetes Mellitus
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean reduction in SBP and DBP from baseline to end of study  Day 7, 15, 30, 60 and 90 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Heart Rate from baseline to end of study.  Day 7, 15, 30, 60 and 90 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "215"
Final Enrollment numbers achieved (India)="206" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2017 
Date of Study Completion (India) 10/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a Comparative, Randomized, Double Blind, Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan Tablets Vs. Losartan Tablets in Patients with Mild Essential Hypertension. Primary Outcome of the study is to study the mean reduction of SBP and DBP in hypertensive patients. 

 
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