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CTRI Number  CTRI/2024/08/071803 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of azelnidipine and cilnidipine in managing type 2 diabetes with hypertension 
Scientific Title of Study   Post-approval, case control analyses to assess clinical safety and effectiveness of Azelnidipine and Cilnidipine as initial -addon therapy in management of T2DM with HTN 
Trial Acronym  HYDIAZ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mayur Patil 
Designation  Principal Investigator 
Affiliation  Marengo CIMS Hospital 
Address  OPD No. 9, 12th floor, CIMS North, Marengo CIMS Hospital, Off Science City Rd, Science City, Panchamrut Bunglows II, Sola,

Ahmadabad
GUJARAT
380060
India 
Phone  9727765779  
Fax    
Email  mayurpatil09@proton.me  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishnaprasad K MD 
Designation  General Manager - Medical Strategic Affairs (India,RoW) 
Affiliation  Torrent Pharmaceuticals Ltd 
Address  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 House, Off Ashram Road, Terapanth Road, Navrangpura,

Ahmadabad
GUJARAT
380009
India 
Phone  7069000560  
Fax    
Email  RathishNair@TorrentPharma.com  
 
Source of Monetary or Material Support  
Dr Mayur Patil, OPD No. 9, 12th floor, CIMS North, Marengo CIMS Hospital, Off Science City Rd, Science City, Panchamrut Bunglows II, Sola, Ahmedabad, Gujarat-380060, India 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mayur Patil  MARENGO CIMS Hospital  OPD No. 9, 12th floor, CIMS North, Marengo CIMS Hospital, Off Science City Rd, Science City, Panchamrut Bunglows II, Sola-380060
Ahmadabad
GUJARAT 		 9727765779

mayurpatil09@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: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
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 with age 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 greater than equal 140/90 mmHg. 
 
ExclusionCriteria 
Details  If patient meeting any of the study exclusion criteria should be excluded from study.

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 at 4W and 12W. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Change from baseline in Blood Pressure (SBP/DBP)

2) Change from baseline in Resting Heart Rate (RHR) 		 Baseline, 4W and 12W 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change from baseline in LVEF.

2) Change from baseline in Sr. creatinine.

3) Change from baseline in UACR for cases with Diabetic Kidney Disease.

4) Change from baseline in Blood Pressure (SBP/DBP) with at least one additional risk factor like Dyslipidemia, Smoking, Family history or Comorbidity like Left ventricular dysfunction, chronic kidney disease with proteinuria less than 300 g/g OR 10y QRISK3 score more than 10%.

5) Change from baseline in Resting Heart Rate (RHR) for cases with 10y- QRISK3 score more than 10%. 		 All assessments will be performed at baseline, 4W and 12W 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   13/08/2024 
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   It is a Post-approval, case control analyses to assess clinical safety and effectiveness of Azelnidipine and Cilnidipine as initial -addon therapy in management of T2DM with HTN.

The objective of the study was to study the impact of Azelnidipine or Cilnidipine as initial addon strategy in the management HTN with T2DM while achieving the treatment goals of </=130/80 mm Hg.

Total 200 patients will be enrolled in this study.

Study drug: Subjects will be treated with either Azelnidipine 8, 16 mg or Cilnidipine 5, 10 mg administered once a day.

 
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