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CTRI Number  CTRI/2017/12/010961 [Registered on: 22/12/2017] Trial Registered Prospectively
Last Modified On: 05/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fixed dose combination of Azilsartan medoxomil and Chlorthalidone for tratment of hypertension 
Scientific Title of Study   A Double Blind, Randomized, Multicentric, Active Controlled, Parallel group, Comparative Phase III study to evaluate the Efficacy and Safety of fixed dose combination of Azilsartan medoxomil and Chlorthalidone versus fixed dose combination of Olmesartan medoxomil and Hydrochlorothiazide in patients with moderate to severe hypertension 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
OLS/SYN/AZCT/17 Version No.:01 Dated: 13 Feb 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Sanjib Panda 
Designation  Head Operation 
Affiliation  Ocius Life Sciences Private Limited 
Address  Department of Clinical Research, No-325, P. H. Road, Aminjikarai

Chennai
TAMIL NADU
600029
India 
Phone  9003580729  
Fax    
Email  sanjib@ociuslife.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Sanjib Panda 
Designation  Head Operation 
Affiliation  Ocius Life Sciences Private Limited 
Address  Department of Clinical Research, No-325, P. H. Road, Aminjikarai


TAMIL NADU
600029
India 
Phone  9003580729  
Fax    
Email  sanjib@ociuslife.com  
 
Details of Contact Person
Public Query  
Name  Mr Sanjib Panda 
Designation  Head Operation 
Affiliation  Ocius Life Sciences Private Limited 
Address  Department of Clinical Research, No-325, P. H. Road, Aminjikarai


TAMIL NADU
600029
India 
Phone  9003580729  
Fax    
Email  sanjib@ociuslife.com  
 
Source of Monetary or Material Support  
SYNOKEM Pharmaceuticals Limited, Synokem House, 14/486, Outer Ring Rd, Block 12, Sunder Vihar, Paschim Vihar, New Delhi, Delhi 110087 
 
Primary Sponsor  
Name  SYNOKEM Pharmaceuticals Limited 
Address  Synokem House, 14/486, Outer Ring Rd, Block 12, Sunder Vihar, Paschim Vihar, New Delhi, Delhi 110087 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravindra L Kulkarni  Ashwin Medical Foundation‟s Moraya Multispeciality Hospital  Department of medicine, Opposite to PMP bus stop , Power House Chowk, Chinchwadgaon , Pune 411033
Pune
MAHARASHTRA 		 9422300251

drravindrakulkarni@gmail.com 
Dr Souren Pal  District Hospital  Department of medicine, Howrah, 10 No. Biplobi Haren Ghosh Sarani, Howrah 700001
Haora
WEST BENGAL 		 9830525360

drsourenpal@gmail.com 
Dr Saurabh Agarwal  GSVM medical College  Department of medicine, post graduate department of Medicine, Swaroop nagar, kanpur 208002
Kanpur Nagar
UTTAR PRADESH 		 9415039582

drsaurabhagarwal.research@gmail.com 
Dr Sanjay Kumar Jangid  Hi tech Medical College & Hopsital  Department of medicine, health park, Pandra, Rasulgarh, Bhubaneswar-751019
Khordha
ORISSA 		 9337671521

drsanjay_jangid@yahoo.co.in 
Dr Saroj Mondal  IPGME & R/SSKM Hospital  Department of medicine, 244, AJC Bose Road, Kolkata
Kolkata
WEST BENGAL 		 9831313714

drsaroj0007@gmail.com 
Dr Sunil Prem Chand Massand  Maharaja Agrasen Hospital  Department of medicine, Punjabi Bagh, New Delhi-110026
New Delhi
DELHI 		 00140777666

sunilmassand@yahoo.com 
Dr A Gopal Rao  Rajiv Gandhi institute of Medical Sciences and RIMS Government General Hospital  Demartment of medicine, Srikakulam, Andhra pradesh-532001
Srikakulam
ANDHRA PRADESH 		 8942279033

drgopalraoa@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
District Hospital Institutional Ethics Committee, Howrah District Hospital  Approved 
Ethics Committee GSVM medical College, GSVM medical College  Approved 
Hi tech Medical College & Hopsital Institutional Ethics Committee, Hi tech Medical College & Hopsital  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences and RIMSGGH  Approved 
Moraya Institutional Ethics Committee, Ashwin Medical Foundation‟s Moraya Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with moderate to severe hypertension.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed dose combination of Azilsartan medoxomil (40 mg) and Chlorthalidone (12.5 mg and 25 mg)  Fixed dose combination of Azilsartan medoxomil and Chlorthalidone to be taken once daily for 12 weeks  
Comparator Agent  Fixed dose combination of Olmesartan medoxomil (20 mg and 40 mg)and Hydrochlorothiazide (12.5 mg)  Fixed dose combination of Olmesartan medoxomil and Hydrochlorothiazide to be taken once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Men and women between 18-65 years of age (Both are inclusive).
2. Newly diagnosed patients or De novo patients are eligible for study.
3. Patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
4. Patient having moderate to severe systolic hypertension (defined as sitting trough clinic systolic blood pressure is between 160 mmHg and 190 mmHg inclusive at screening visit)
5. Patients with sitting diastolic hypertension (DBP) <119 mmHg at screening visit
6. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
7. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator 
 
ExclusionCriteria 
Details  1. Clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders.
2. Hypersensitive to angiotensin II receptor blockers or diuretics or any ingredient of the formulation.
3. Recent history (within the last 6 months) of myocardial infarction, Patients with NYHA class III and IV heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
4. Clinically relevant or unstable cardiovascular diseases
5. Type 1 or poorly controlled type 2 diabetes mellitus (HbA1c: ≥ 8%).
6. Pregnant, nursing women or women with childbearing potential not using medically approved means of contraception
7. Patients taking any antihypertensive or concomitant medications known to affect BP.
8. History of drug or alcohol abuse or those who smoke >1 pack of cigarettes per day
9. Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.
10. Secondary hypertension of any etiology.
11. Subject who have used any investigational drug or device within 30 days or 5 half-lives of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
12. Any other disease state which could interfere with trial participation or trial evaluation as per investigator‟s discretion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure  Day 1, Day 28, Day 42 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure  Day 1, Day 28, Day 42 and Day 84 
Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure Monitoring  Day 1 and Day 84 
Percentage of responders at the end of 12 weeks of the treatment period  Day 28, Day 42 and Day 84 
 
Target Sample Size   Total Sample Size="306"
Sample Size from India="306" 
Final Enrollment numbers achieved (Total)= "306"
Final Enrollment numbers achieved (India)="306" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/12/2017 
Date of Study Completion (India) 04/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
High blood pressure is a long term medical condition and is the most common modifiable risk factor for cardiovascular disease and death. Single drug therapy remains the preferred way to begin treatment of hypertension, although in some patients this is unable to bring blood pressure (BP) to goal levels.
This study drug is an anti-hypertensive tablet which is a fixed dose combination  (FDC) of Azilsartan medoxomil, an inhibitor of the reninangiotensin-
aldosterone system and Chlorthalidone, a thiazide-type diuretic. Thus current study aims to evaluate the efficacy and safety of FDC of Azilsartan medoxomil and chlorthalidone in Indian population patient having moderate to severe Hypertension. Study composed of total 6 visits with approximately 84 days (12 weeks). Total 306 patients will be randomized in 1:1 ratio for test drug and control drug. Efficacy will be determined on the measurement of Systolic blood pressure and diastolic blood pressure.
 
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