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CTRI Number  CTRI/2015/01/005346 [Registered on: 05/01/2015] Trial Registered Prospectively
Last Modified On: 04/09/2015
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 trial to Study the effects of 3 different doses of Azilsartan Medoxomil 20mg, 40mg and 80 mg in comparison with 2 different doses Telmisartan 20mg and 40 mg in Indian patients with high blood pressure.  
Scientific Title of Study   An Open Label, Three Arm, Randomized, Prospective, Multicentric, Phase III Clinical study to evaluate and compare the efficacy and safety of Azilsartan Medoxomil Tablets 20mg, Azilsartan Medoxomil 40mg & Azilsartan Medoxomil 80mg with Telmisartan Tablets 20mg & 40mg in Indian Adults patients of Essential hypertension with or without associated Cardiovascular Complications 
Trial Acronym  AZTE 
Secondary IDs if Any  
Secondary ID  Identifier 
NEX/AZL/CTIII5004/05/2011, Version No. 05, dated. 02.11.2013  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 Amit Bhatt 
Designation  President & CEO  
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  32 A, Nexus Center for Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai- Pune Highway, Nerul (East) Mumbai (Suburban) MAHARASHTRA 400706 India

Mumbai
MAHARASHTRA
400706
India 
Phone  02227714204   
Fax    
Email  dramit.bhatt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mangesh Khadakban 
Designation  Project Manager 
Affiliation  Nexus Clinical Research (India) Ltd.  
Address  32 A, Nexus Center for Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai- Pune Highway, Nerul (East) Mumbai (Suburban) MAHARASHTRA 400706 India

Mumbai
MAHARASHTRA
400706
India 
Phone  02227714402  
Fax    
Email  Mangesh.Khadakban@nexuscro.com  
 
Source of Monetary or Material Support  
MSN Laboratories Pvt. Ltd.  
 
Primary Sponsor  
Name  MSN Laboratories Pvt Ltd  
Address  MSN Laboratories Private Limited Research & Development Center Plot No 12, Industrial Park, Phase IV, Pashamylaram, Patancheru Mandal, Medak - 502 307  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramnarayan Mundada  Ashirwad Hospital and Research Centre  Dept. of General Medicine, Near Jijamata Udyan, Maratha Section, Ulhasnagar- 421004, Maharashtra India
Thane
MAHARASHTRA 		 0251-2587006

rmm03@in.com 
Dr Sanjay Kumar Jangid  Hitech Medical College & Hospital  Dept. of Medicine, Health Park Pandra, Rasulgarh, Bhubaneshwar, Pin 751025, Odisha, India
Cuttack
ORISSA 		 0674-2371406

drsanjay_jangid@yahoo.co.in 
Dr MVV Gandhi  King George Hospital   Department of Medicine, Maharanipeta, Visakhapatnam, Andhra Pradesh – 530002
Visakhapatnam
ANDHRA PRADESH 		 9912940602

drgandhiclinicalresearch@gmail.com 
Dr Radheshyam Chejara   S.M.S. Medical College & Hospital  Department of Internal Medicine, Dhanwantri OPD Block, JLN Marg, Jaipur – 302004, India
Jaipur
RAJASTHAN 		 0141-2560291

drchejara@gmail.com 
Dr Shafali Nandwani  Subharti Medical College and Hospital  Dept. of Medicine, Unit II Subhartipuram, NH-58, Haridwar Delhi Bypass Road, Meerut – 250005, Uttar Pradesh
Meerut
UTTAR PRADESH 		 0121-2439112

drmahip@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar, Odisha 751025   Approved 
Institutional ethics Committee Ashirwad Hospital and Research Centre, Near Jijamata Udyan, Maratha Section, Ulhasnagar- 421004, Maharashtra India  Approved 
Institutional Ethics Committee, King George Hospital, Vishakhapatnam-530002, Andhra Pradesh  Approved 
Institutional Ethics Committee, Subharti Medical College and Hospital, Subhartipuram, NH-58, Meerut (U.P.)  Submittted/Under Review 
The Ethics Committee, S.M.S. Medical College and Attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adults patients of Essential hypertension with or without associated Cardiovascular Complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tablet Azilsartan Medoxomil 20 mg  20 mg tablet to be taken once daily for the first 14 days 
Intervention  Tablet Azilsartan Medoxomil 40 mg  20 mg tablet to be taken once daily for the first 14 days than the dose is eventually to be titrated to 40 mg which is to be taken once daily for the next 28 days.  
Intervention  Tablet Azilsartan Medoxomil 80 mg   20 mg tablet to be taken once daily for the first 14 days than the dose is eventually to be titrated to 80 mg which is to be taken once daily for the next 28 days.  
Comparator Agent  Tablet Telmisartan 20 mg  20 mg tablet to be taken once daily for the first 14 days  
Comparator Agent  Tablet Telmisartan 40 mg  20 mg tablet to be taken once daily for first the 14 days and than the dose is eventually to be titrated to 40 mg which to be taken once daily for 28 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female patients of age between 18-65 years.
2.Patients or patient’s legally acceptable representative willing to sign the Informed Consent Form.
3.Patients newly diagnosed (first-time diagnosis during screening or within three months before the first day of screening) with Essential Hypertension of Stage 1 with SBP ranging between 140 159 mmHg and / or DBP ranging between 90-99 mmHg.
4.Patients currently:
a) on anti-hypertensive drug therapy (for phase A as well as phase B) or
b) without anti-hypertensive drug therapy (for phase B only)
5.Female patients of childbearing potential who are sexually active must agree to use adequate contraception, and should neither be pregnant nor lactating from screening throughout the duration of the study
6.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.
7.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable).
 
 
ExclusionCriteria 
Details  1.Patients (essentially ‘newly diagnosed’) who will be at a significant medical risk arising out of deprivation of regular anti-hypertensive drug treatment during the washout period.
2.Patients with a history of chronic kidney disease, renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea.
3.Patients with severe renal impairment (eGFR <60 mL/min/1.73 m2).
4.Patients with severe hepatic impairment [SGOT, SGPT and S. Bilirubin (total) ≥1.5 times the upper limit of normal reference values].
5.Patients with history of hyperkalemia.
6.Patient with known history of unstable cardiovascular disease and/or significant cardiac conduction defects.
7.Patient with Type 1 or Type 2 Diabetes Mellitus.
8.Known history of gout.
9.Patients suffering from pre-existing severe cough.
10.Patients with history of cardiac surgery in past 3 months prior to screening.
11.Known or suspected hypersensitivity to any drug that will be administered during the study.
12.Inability to comply with the protocol requirements.
13.Participation in any other clinical trial within 3 months of registering in this trial.
14.Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy:
Mean reduction in the trough sitting clinic SBP and DBP from baseline to Day 14 (±2) and Day 43(+1)

Safety:
Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug. 		 Efficacy:
Baseline to each post randomization visit [Day1, 14, 42 and 43]

Safety:
Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43]
Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]  
 
Secondary Outcome  
Outcome  TimePoints 
Change in 24 hour mean (average of all measurements for 24 hours) SBP and DBP.  On day 43 (or 44) as compared to baseline 
 
Target Sample Size   Total Sample Size="255"
Sample Size from India="255" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/01/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Azilsartan medoxomil is an angiotensin II AT1 receptor blocker indicated for the treatment of hypertension to lower the blood pressure. Lowering the blood pressure reduces the risk of fatal and non fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs form a wide variety of pharmacological classes including the class to which this drug primarily belongs. There are no controlled trials demonstrating risk reduction with Azilsartan Medoxomil.

Control of high blood pressure should be a part of comprehensive cardiovascular risk management, including, as appropriate lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood  pressure goals.

Numerous antihypertensive drugs from a variety of pharmacological classes and different mechanisms of action, have been shown in randomized controlled clinical trials to reduce cardiovascular morbidity and mortality.

Thus in this study, efficacy and safety of Azilsartam medoxomil 20mg and 40 mg and tablet Azilsartan medoxomil 80 mg will be compared with Telmisartan 20mg and 40 mg tablet in patients with essential hypertension associated with or without cardiovascular complication.         
 
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