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CTRI Number  CTRI/2024/07/071061 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study on safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic Hypertension. 
Scientific Title of Study   Post-approval, observational study to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN 
Trial Acronym  TELAZ 
Secondary IDs if Any  
Secondary ID  Identifier 
TPL2403479_Version00_14May24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagdeep Shah 
Designation  Investigator 
Affiliation  Gujrat Kidney Foundation 
Address  Gujrat Kidney Foundation, 4-5th Floor, Shaival Complex, Near Suvidha Shopping Centre, Paldi, Ahmedabad, Gujarat 380007

Ahmadabad
GUJARAT
380007
India 
Phone  7948983895  
Fax    
Email  jagdeepshah@proton.me  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishnaprasad K MD  
Designation  General Manager - Medical Strategic Affairs 
Affiliation  Torrent Pharmaceuticals Ltd 
Address  Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road Terapanth Road Navrangpura

Ahmadabad
GUJARAT
380009
India 
Phone  7069000572   
Fax    
Email  krishnaprasadkorukonda@torrentpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Rathish Nair PhD MBA  
Designation  Assistant General Manager - Medical Strategic Affairs 
Affiliation  Torrent Pharmaceuticals Ltd. 
Address  Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road Terapanth Road Navrangpura

Ahmadabad
GUJARAT
380009
India 
Phone  7069000560   
Fax    
Email  rathishnair@torrentpharma.com  
 
Source of Monetary or Material Support  
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India 
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Ltd.  
Address  Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagdeep Shah   Gujrat Kidney Foundation  4-5th Floor, Shaival Complex, Near Suvidha Shopping Centre, Paldi, Ahmedabad, Gujarat 380007
Ahmadabad
GUJARAT 		 7948983895

jagdeepshah@proton.me 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azelniidpine and Telmisartan  Dose:Azelniidpine 8-16 mg & Telmisartan 20/40/80 mg Route of administration: Oral Duration: 5 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or Female patients 18 to 65 years.
2.Known cases of T2DM with HTN as Treatment naïve or uncontrolled receiving background ARB therapy for at least four weeks
3.Patients with systemic Blood pressure ≥140/90 mm/Hg.
 
 
ExclusionCriteria 
Details  1.Patients with T1DM.
2.Patients with impaired hepatic function with liver enzymes 5X ULN
3.Current state as pregnant or breast-feeding
4.Patients not willing for follow –up during the course of the study @ 8W and 24W
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in Blood Pressure (SBP/DBP) at 4W and 12W
Change from baseline in Resting Heart Rate (RHR) at 4W and 12W
 		 Baseline, 4 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in LDL-C & Non-HDL-C levels at 4W and 12W  Baseline, 4 weeks and 12 weeks
 
Change in HbA1c at 12W.  Baseline, 4 weeks and 12 weeks
 
Change from baseline in eGFR at 4W and 12W for cases with Diabetic Kidney Disease   Baseline, 4 weeks and 12 weeks 
Change from baseline in Blood Pressure at 4W and 12W with at least one additional risk factor (Dyslipidemia, Smoking, Family history) or Comorbidity (Left ventricular dysfunction, chronic kidney disease with proteinuria) OR 10y QRISK3 score less than 10 percentage   Baseline, 4 weeks and 12 weeks 
Change from baseline in Resting Heart Rate at 4W and 12W for cases with 10y- QRISK3 score less than 10 percentage  Baseline, 4 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="7000"
Sample Size from India="7000" 
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   N/A 
Date of First Enrollment (India)   02/08/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of this study is to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN.
Study design: Post-approval observational study.
Duration of observation : 12 weeks
Study drug:Azelnidipine 8/16 mg and Telmisartan 20/40/80 mg
 
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