| CTRI Number |
CTRI/2025/10/095719 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of telmisartan and amlodipine combination vs telmisartan in Indian patients with high blood pressure |
|
Scientific Title of Study
|
To assess the safety and effectiveness of telmisartan/amlodipine in comparison to telmisartan in Indian patients with hypertension through a real-world, retrospective, Observational study (CONTROL Study) |
| Trial Acronym |
CONTROL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2507021, Version: 00, Dated: 09-09-2025 |
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 |
Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000639 |
| Fax |
|
| Email |
mukeshgabhane@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009
GUJARAT
380009
India |
| Phone |
7069000639 |
| Fax |
|
| Email |
mukeshgabhane@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009
GUJARAT
380009
India |
| Phone |
7069000639 |
| 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 Mukesh Gabhane |
Medical Affairs, Torrent Pharmaceuticals Ltd. |
Off. Ashram Road, Terapanth Rd, Navrangpura
Ahmadabad
GUJARAT |
7069000639
mukeshgabhane@torrentpharma.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-I16||Hypertensive diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult Male or female patients with newly diagnosed hypertension (BP more than 140/90 mmHg)
2. Patients diagnosed with hypertension and treated with telmisartan & amlodipine combination or telmisartan monotherapy as initial line therapy |
|
| ExclusionCriteria |
| Details |
1. Patients with current or past exposure to antihypertensive medications other than study drug |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Mean change in seated SBP & DBP |
from baseline at 12±2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Proportion of patients achieving BP control (defined as mean seated SBP less than 130 mmHg and DBP less than 80 mmHg). |
at 12±2 weeks |
| 2. Proportion of patients who sustained or improved on BP control achieved |
at 12±2 weeks over 24±2 weeks |
| 3. Incidence of adverse events |
at any subsequent visit post baseline |
|
|
Target Sample Size
|
Total Sample Size="14000"
Sample Size from India="14000"
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)
|
17/10/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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, observational, open-label study with an objective to evaluate the tolerability and effectiveness of telmisartan and amlodipine combination in comparison to telmisartan monotherapy as initial-line therapy in treatment-naïve Indian adults with newly diagnosed hypertension.
The Endpoints of the study are as follows- 1. Primary Endpoints: - Mean change in seated SBP & DBP from baseline at 12±2 weeks 2. Secondary Endpoints: - Proportion of patients achieving BP control (defined as mean seated SBP <130 mmHg and DBP <80 mmHg) at 12±2 weeks. - Proportion of patients who sustained or improved on BP control achieved at 12±2 weeks over 24±2 weeks - Incidence of adverse events
Data of approximately 14,000 patients across India will be collected for the purpose of this study. The available data must meet all the following criteria to be included in the study:
1. Inclusion Criteria - Adult Male or female patients with newly diagnosed hypertension (BP >140/90 mmHg) - Patients diagnosed with hypertension and treated with telmisartan & amlodipine combination or telmisartan monotherapy as initial line therapy 2. Exclusion Criteria - Patients with current or past exposure to antihypertensive medications other than study drug |