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CTRI Number  CTRI/2025/08/093314 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to understand clinical utility of Nebivolol and Telmisartan combination in Indian patients with Hypertension. 
Scientific Title of Study   Drug utilization pattern and tolerability of Nebivolol-Telmisartan combination in Indian Hypertensive Patients: A retrospective cross-sectional study (INTEL-HT) 
Trial Acronym  INTEL-HT 
Secondary IDs if Any  
Secondary ID  Identifier 
TPL2502105, Version- 00, Dated- 07/05/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Gabhane 
Designation  Assistant General Manager 
Affiliation  Torrent Pharmaceuticals Ltd. 
Address  Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India

Ahmadabad
GUJARAT
380009
India 
Phone  07069000639  
Fax    
Email  mukeshgabhane@torrentpharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Gabhane 
Designation  Assistant General Manager 
Affiliation  Torrent Pharmaceuticals Ltd. 
Address  Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India


GUJARAT
380009
India 
Phone  07069000639  
Fax    
Email  mukeshgabhane@torrentpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh Gabhane 
Designation  Assistant General Manager 
Affiliation  Torrent Pharmaceuticals Ltd. 
Address  Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India


GUJARAT
380009
India 
Phone  07069000639  
Fax    
Email  mukeshgabhane@torrentpharma.com  
 
Source of Monetary or Material Support  
Torrent Pharmaceuticals Ltd. Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009 
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Ltd. 
Address  Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Maulik Kinariwala  Shreeyanta Diabetes & Metabolic Clinic   212-217 Second Floor, Swanik Arcade, K k nagar Road,Near Arjun Hommes,Naranpura,Ahmedabad
Ahmadabad
GUJARAT 
9898031820

tpl.sitemanagement@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sangini 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, (2) ICD-10 Condition: I15||Secondary hypertension, (3) ICD-10 Condition: I11||Hypertensive heart disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients aged more than or equal to 18 years
2. Patients diagnosed with hypertension and treated with FDC of nebivolol and telmisartan 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients with hypertension on FDC of Nebivolol and telmisartan who also have diabetes  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of newly diagnosed patients with hypertension on FDC of Nebivolol & telmisartan who also have diabetes
2. Proportion of patients on fixed dose combination of nebivolol & telmisartan experiencing adverse events 
Baseline 
 
Target Sample Size   Total Sample Size="15000"
Sample Size from India="15000" 
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)   01/09/2025 
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)  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  

Hypertension is a leading modifiable risk factor for cardiovascular morbidity and mortality worldwide, accounting for approximately 9.4 million deaths annually and 7 percent of global disability-adjusted life years. In India, the condition is particularly alarming, contributing to nearly 10 percent of all deaths, with prevalence rates ranging from 4–15 percent in urban and 2–8 percent in rural populations. Despite the availability of various antihypertensive agents, many patients require combination therapy for optimal control. Nebivolol, a third-generation beta1-selective blocker, not only reduces blood pressure but also enhances vasodilation via nitric oxide release. Telmisartan, a long-acting angiotensin II receptor blocker (ARB), offers potent and sustained antihypertensive effects with good tissue penetration. Combining these two agents, which have complementary mechanisms of action, may offer superior blood pressure control in patients inadequately managed by monotherapy.

To assess the usage pattern and safety of the fixed-dose combination (FDC) of nebivolol and telmisartan in clinical practice, a retrospective, multicentric data collection study involving approximately 15,000 hypertension patients is planned across various sites in India. Data of  male or female patients aged more than 18 years and patients diagnosed with hypertension and treated with FDC of nebivolol and telmisartan will be collected and analyzed for this study.

 
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