| CTRI Number |
CTRI/2026/01/100848 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Understand the effects of Telmisartan and Metoprolol Combination Tablets in Indian Patients with High Blood Pressure |
|
Scientific Title of Study
|
A Retrospective, Observational, Multicentric Study Targeted to assess the Effectiveness, Tolerability and Preferred Patient Profile for Fixed Dose Combination of Telmisartan and Metoprolol in Indian Patients with Hypertension (TARGET BETA-2 Study) |
| Trial Acronym |
Target Beta-2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2505008, Version- 01, Dated- 10/06/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh R V |
| Designation |
General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
GUJARAT
380009
India |
| Phone |
917069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Chouksey |
| Designation |
Assistant General Manager, Medical Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
7th floor RD side, Torrent House, Off Ashram Road, Ahmedabad – 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917069000413 |
| Fax |
|
| Email |
narendrachouksey@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Torrent House, Off Ashram Road, Ahmedabad – 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off Ashram Road, Ahmedabad – 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RAGHU SATYANARAYAN |
Radiance Hospital |
2nd Floor, Akshar Arcade, Opposite Memnagar Fire Station; 5th Floor, Ankur Complex, Ankur Road, Naranpura Vistar
Ahmadabad
GUJARAT |
9825015533
raghu_satyanarayan@yahoo.com |
| Dr CHIRAYU VYAS |
Rhythm Solutions |
708, 7th Floor, Shivalik Square Complex, 132 Feet BRTS Ring Road, Nava Vadaj
Ahmadabad
GUJARAT |
9924148081
cpvyas77@yahoo.com |
| Dr ANKIT KATARIYA |
Spandan Heart Care |
18 ABC Complex Opp Rabari Colony BRTS bus stop, Nikol
Ahmadabad
GUJARAT |
8905956146
ADKATARIYA@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, |
|
|
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. Patients who were prescribed FDC of Telmisartan and Metoprolol XR (any dosage) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Change in SBP and DBP |
Baseline and Post 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in heart rate in patients with and without tachycardia. |
Baseline and Post 30 days |
1. Patient profile and time taken (in years) to switchover to dual therapy from monotherapy.
2. Proportion of naïve hypertensives, started with dual therapy. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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)
|
25/01/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
This is a real world, retrospective, multicentric, observational study wherein data of patients visiting to various clinics across India are collected in suitably designed Data Collection Form (DCF). The objective of the study is to retrospectively access the effectiveness, tolerability and preferred patient profiles for FDC of Telmisartan and Metoprolol in the management of Hypertension in real world outpatient settings of India. STUDY ENDPOINTS are as follows- - Change in heart rate in patients with and without tachycardia
- Patient profile and time taken (in years) to switchover to dual therapy from monotherapy.
- Proportion of naïve hypertensives, started with dual therapy
Data for approximately 10,000 patients across India will be collected for the purpose of this study who meets the following criteria- - Patients who were prescribed FDC of Telmisartan and Metoprolol XR (any dosage)
The present study is a retrospective data collection study. Basic statistical analysis will be performed on all collected data. The data will be compiled, and subjected to analysis. |