| 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
|
|
|
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
|
|
|
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 |
|
|
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. |