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CTRI Number  CTRI/2024/03/064100 [Registered on: 13/03/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the safety and efficacy of Efonidipine + Telmisartan in the treatment of hypertension.  
Scientific Title of Study   A multicentric, open label study to evaluate the safety and efficacy of fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in the management of Stage II hypertension. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
FDC-CT-06-05/2024  DCGI 
ZUV/EFNOCAR-T/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhupesh Dewan 
Designation  Director 
Affiliation  Zuventus Healthcare Limited 
Address  Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai

Mumbai
MAHARASHTRA
400078
India 
Phone  912235060000  
Fax    
Email  bhupesh.dewan@zuventus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupesh Dewan 
Designation  Director 
Affiliation  Zuventus Healthcare Limited 
Address  Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai


MAHARASHTRA
400078
India 
Phone  912235060000  
Fax    
Email  bhupesh.dewan@zuventus.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhupesh Dewan 
Designation  Director 
Affiliation  Zuventus Healthcare Limited 
Address  Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai


MAHARASHTRA
400078
India 
Phone  912235060000  
Fax    
Email  bhupesh.dewan@zuventus.com  
 
Source of Monetary or Material Support  
Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai, 400078 Maharashtra 
 
Primary Sponsor  
Name  Zuventus Healthcare Limited 
Address  Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai, 400078 Maharashtra 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujata Devi  AIIMS, Bhubaneswar  Department of General medicine, Ground floor, Room No. 45, Sijua, patrapada, Bhubaneswar
Khordha
ORISSA 		 9438884203

sujiankita@gmail.com 
Dr Govardhan Rao M V  Excel Hospital  Department of General medicine, 1st floor, Room no. 103, 1-5-56/29, Old Alwal Road, Near IG Statue, Banda Basti, Old ALwal, Secunderabad
Medchal
TELANGANA 		 9948181288

drgovardhanmd1278@gmail.com 
Dr Amit Kumar  King Georges Medical University  Department of General medicine, Gandhi Ward, Ground Floor, Room no. 19, King George Madical University Chowk, Shah Mina Rd.
Lucknow
UTTAR PRADESH 		 8953277707

amitgupta311226@gmail.com 
Dr Dnyaneshwar Halnor  Kkasturi Medicare Pvt. Ltd.  Room No. 4, Ground Floor, Harshniketan, Gaondevi road, Behind Navrang Hotel, Bhayander (W)
Thane
MAHARASHTRA 		 9082805199

drdnyaneshwarhalnorvvh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Excel Hospital Institutional Ethics Committee  Approved 
Institutional Ethics Committee KGMU  Approved 
lnstitutional Ethics Committee AIIMS Bhubaneswar  Approved 
Shah Lifeline Hospital and Heart Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg Tablets  Fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets to be taken once daily for 90 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults with age 18 years and above 2. Patients diagnosed with Stage II hypertension (SBP/DBP: 160/100 mmHg or above) 3. Naïve patients or patients able to switch from their current antihypertensive therapy without any risk to the patient on the investigator opinion 4. Patients willing to sign informed consent. 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to angiotensin II receptor blockers or dihydropyridine calcium channel blockers
2. Patients with history of severe, malignant or secondary hypertension
3. Patient with cerebrovascular disease in the previous 3 months
4. Patients with chronic arrhythmia, sick sinus syndrome or sinus bradycardia (less than 50 beats per min)
5. Patients with second or third degree atrioventricular block
6. Female patients who are pregnant, lactating 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of patients reporting incidences of adverse events  Day 0 to Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Mean reduction in sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)  Day 30, 60 and 90 
Number of patients achieving/maintaining the target BP as per JNC VIII guideline for Hypertension.  Day 90 
 
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   Phase 4 
Date of First Enrollment (India)   20/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   This is an open-label trial to evaluate the safety and efficacy of the fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in Stage II hypertension. The adverse events will be monitored during the 90 days of treatment period. The efficacy in reducing blood pressure and a number of patients achieving or maintaining the target blood pressure will be evaluated in this Phase IV trial. 
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