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CTRI Number  CTRI/2014/08/004840 [Registered on: 07/08/2014] Trial Registered Prospectively
Last Modified On: 20/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A phase-III clinical trial to study the effects of Azilsartan in Indian patients of hypertension. 
Scientific Title of Study   A Comparative, Phase III, Multi-Center Study to Evaluate the Efficacy, Tolerability, and Safety of Azilsartan in Indian Adult Patients of Hypertension (AZILEHI Study)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/AZILEHI/10/2012, Version No.1.1, dated 04-Oct-2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice-President and Head 
Affiliation  Hetero Group 
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice-President and Head 
Affiliation  Hetero Group 
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India, Tel: 91-40-23704923/24/25, Fax: 91-40-23801902  
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India 
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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrManojit LodhaMD DM  Institute of Postgraduate Medical Education & Research   Department of Cardiology, Institute of Postgraduate Medical Education & Research (IPGMER), Kolkata- 700020.
Kolkata
WEST BENGAL 		 033-22235181

manojit.lodha@gmail.com 
Dr P Naveen Chander Reddy MD   Mediciti Hospital  Mediciti Hospital,5-9-22,Secratariat Road,Hyderabad - 500063
Hyderabad
ANDHRA PRADESH 		 040-23231111

podduturunaveen@yahoo.co.in 
Dr Rakesh Kumar Sahay DNB MD Med DM   Osmania General Hospital  Department of Endocrinology, Osmania General Hospital, Afzalgunj, Hyderabad-500012
Hyderabad
ANDHRA PRADESH 		 040-24651667

sahayrk@gmail.com 
Dr K Sunil Naik MD  Rajiv Gandhi Institute of Medical Sciences  Rajiv Gandhi Institute of Medical Sciences, Srikakulam, AP
Srikakulam
ANDHRA PRADESH 		 9440828299

rimsresearch@gmail.com 
Dr Ashwini Mehta MD DM   Sir Gangaram Hospital  Department of Cardiology, Sir Gangaram Hospital, New Delhi-110060.
New Delhi
DELHI 		 011-43595566

drashwanimehta@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics committee , Osmania Medical college  Submittted/Under Review 
IEC-RIMS  Approved 
IPGME&R Over Site Committee,(Institutional ethics committee for research involving human subjects)  Submittted/Under Review 
Mediciti Ethics Committee  Approved 
Sir Gangaram 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: R030||Elevated blood-pressure reading, without diagnosis of hypertension, Mild to moderate Essential Hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azilsartan medoxomil 20mg, 40mg and 80mg tablets  Azilsartan medoxomil 20mg tablets orally, once daily for two weeks, increased to 40mg, once daily for four weeks.  
Intervention  Azilsartan medoxomil 20mg, 40mg and 80mg tablets  Azilsartan medoxomil 20mg tablets orally, once daily for two weeks, increased to 80mg, once daily for four weeks 
Comparator Agent  Telmisartan 20mg, 40mg tablets  Telmisartan 20mg tablets orally, once daily for two weeks, increased to 40mg once daily for four weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
2.Patients with mild to moderate essential hypertension (defined as sitting trough clinic systolic blood pressure between 140 mmHg and 180 mmHg inclusive at Day minus 1 and 24-hour mean systolic blood pressure between 130 mmHg and 170
mmHg inclusive at Day 1). Sitting trough clinic diastolic blood pressure <114mmHg at Day minus 1.
3.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
4.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
5.Willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the patient is on amlodipine prior to screening, the patient is willing to discontinue this medication at Screening Day minus 28.
 
 
ExclusionCriteria 
Details  1. Required to take or continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
2. Hypersensitive to angiotensin II receptor blockers.
3. Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
4. 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 (Stable coronary artery disease (CAD) patients more than 3 months duration with or without angioplasty can be included).
5. Clinically significant cardiac conduction defects (e.g., 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
6. Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
7. Secondary hypertension of any etiology.
8. Non-compliant with the study medication or any study related procedures
9. Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30mL per min/1.73m2) at screening.
10. Known or suspected unilateral or bilateral renal artery stenosis.
11. History of drug or alcohol abuse within the past 2 years.
12. Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those patients with basal cell or Stage 1 squamous cell carcinoma of the skin).
13. Hyperkalemia as defined by the central laboratory normal reference range at screening.
14. Upper arm circumference less than 24 cm or greater than 42 cm.
15. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening.
16. Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
17. Any other serious disease or condition at screening (or randomization) that would compromise patient safety, might affect life expectancy, or make it difficult to successfully manage and follow the patient according to the protocol.
18. Participated and treated in a previous study with azilsartan or a sartan, ACE inhibitors, and ANP & BNP inhibitors, within 30 days prior to randomization.
19. Patients with any other serious concurrent medical or surgical illness or malignancy
20. Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE.
21. Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion
22. Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period
23. The physician is of the opinion that changing a patient’s trial medications would put the patient at risk
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure   Start to end of week 6 of study treatments 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
 		 Start to end of week 6 of study treatments 
Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure Monitoring
 		 Start to end of week 6 of study treatments 
 
Target Sample Size   Total Sample Size="303"
Sample Size from India="303" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/08/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of Azilsartan Test product (Hetero) and Reference product in mild to moderate essential hypertension.

The primary objective is to study the efficacy of azilsartan in Indian adult patients of essential hypertension. The secondary objectives are to evaluate the tolerability and safety of azilsartan in Indian adult patients of essential hypertension.

 
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