CTRI

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CTRI Number

CTRI/2026/04/108722 [Registered on: 20/04/2026] Trial Registered Prospectively

Last Modified On:

15/09/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical study to evaluate the effectiveness,safety and tolerability of a fixed Dose Combination of Bisoprolol Fumarate ,Telmisartan and Chlorthalidone in patients with uncontrolled Hypertension

Scientific Title of Study

A multicentric, randomized, prospective, double blind, parallel group, comparative, active-controlled, Phase III clinical trial to evaluate the efficacy, safety & tolerability of Fixed-Dose Combination of Bisoprolol Fumarate 5 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg Tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg Tablet in patients with Uncontrolled Essential Hypertension with Stable Coronary Artery Disease (CAD).

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
ICS/WIN/2026-002 Ver 1.0 Dated 28 JAN 2026	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Mr Kartik Sahni
Designation	Director
Affiliation	Insignia Clinical Services
Address	512 Best Sky Tower Netaji Subhash Place Pitampura New Delhi DELHI 110034 India North West DELHI 110034 India
Phone	9868679414
Fax
Email	kartik.sahni@insigniacs.com

Details of Contact Person
Scientific Query

Name	Mr Kartik Sahni
Designation	Director
Affiliation	Insignia Clinical Services
Address	512 Best Sky Tower Netaji Subhash Place Pitampura New Delhi DELHI 110034 India North West DELHI 110034 India
Phone	9868679414
Fax
Email	kartik.sahni@insigniacs.com

Details of Contact Person
Public Query

Name	Mr Kartik Sahni
Designation	Director
Affiliation	Insignia Clinical Services
Address	512 Best Sky Tower Netaji Subhash Place Pitampura New Delhi DELHI 110034 India North West DELHI 110034 India
Phone	9868679414
Fax
Email	kartik.sahni@insigniacs.com

Source of Monetary or Material Support

Windlas Biotech Limited,40/1, Mohabewala Industrial Area, Dehradun – 248 110. Uttarakhand, India

Primary Sponsor

Name	Windlas Biotech Limited
Address	40/1, Mohabewala Industrial Area, Dehradun – 248 110. Uttarakhand, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Windlas Biotech Limited	40/1, Mohabewala Industrial Area, Dehradun – 248 110. Uttarakhand, India

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 8
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kamaldeep Y Chawla	Aman Hospital & Research Center	15, Shashwat, Opp. ESI Hospital, Gotri Road, Vadodara – 391101 Vadodara GUJARAT	6356874959 kamaldeepchawla5@gmail.com
Dr Poojari Haribabu	Government Medical College & Government General Hospital	Department of Cardiology, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam, Andhra Pradesh-532001, India Srikakulam ANDHRA PRADESH	9948741133 drharibabupggh@rediffmail.com
Dr Dhananjay Vikram Zutshi	Gunjkar Multispeciality Hospital	Plot No. 315, sec.No.-18, Cardiology Department Room No.3 Ground Floor Gunjkar multispeciality Hospital, Spine Road, Shivtej Nagar, Spine Road, PCMC Pune-411019 Pune MAHARASHTRA	9855844417 drdhananjayz.gunjkarhospital@gmail.com
Dr Gouranga Sarkar	Health Point Hospital	21 Prannath Pandit Street Opposite Lansdowne Paddapukur Kolkata West Bengal - 700025 India Kolkata WEST BENGAL	9830165760 drguranga.sarkar@gmail.com
Dr Awadhesh Kumar Sharma	LPS Institute of Cardiology GSVM Medical College	LPS Institute of Cardiology GSVM Medical College, Kanpur-208002, UP, India Kanpur Nagar UTTAR PRADESH	9501958808 awakush@gmail.com
Dr Subhashis Chakraborty	NRS medical college and Hospital	138, AJC Bose Road, Sealdah, kolkata - 700014 Kolkata WEST BENGAL	9007121311 dr.subhashis1980@gmail.com
Dr K Bhargavi	PCRI PCRI Hospitals Pvt. Ltd	153 srinagar Padugupadu before NH 67, NTS gate , Srinagar, Nellore, Andhra Pradesh - 524137, India Nellore ANDHRA PRADESH	9885891311 bhargavi@pcripl.com
Dr Srinidhi Hegde	Sri Jayadeva Institute of Cardiovascular Sciences and Research	Sri Jayadeva Institute of Cardiovascular Sciences and Research, Kumbarkoppal, Vijaynagar, Gokulam 3rd Stage, Mysuru, Karnataka-570016 Mysore KARNATAKA	9886884971 dr.srihegde@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 8
Name of Committee	Approval Status
Ethics Committee GSVM Medical College	Approved
HEALTH POINT ETHICS COMMITTEE	Approved
IEC-SJICSR	Approved
Institutional Ethics Committee	Submittted/Under Review
Institutional Ethics Committee - Aman Hospital and Research Center	Approved
Institutional Ethics Committee Gunjkar Multispeciality Hospital	Approved
Institutional Ethics Committee, Government General Hospital, Srikakulam	Approved
PCRI 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 Bisoprolol Fumarate 5 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg tablets.	Oral Tablets for 84 Days
Comparator Agent	Fixed-Dose Combination of Metoprolol Succinate ER 50 mg, Telmisartan 40 mg and Chlorthalidone 12.5 mg tablets.	Oral Tablets for 84 Days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Willing to give consent to participate 2. Female or male aged 18-65 (both inclusive) years at the time of consent. 3. Patients must have uncontrolled essential hypertension with stable coronary artery disease (CAD) having mean seated SBP less than 140 to 179 and DBP of less than 90 to 109 mmHg despite being on a stable regimen of dual anti-hypertensive for at least 4 weeks prior to study entry. 4. Must demonstrate a mean seated SBP less than 140-179 and DBP less than 90-109 mmHg; [Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit]. 5. Have no change in background therapy regimen and dose consisting of a stable regimen of dual anti-hypertensive agents including a beta-blocker such as Bisoprolol Fumarate 5 mg (or equivalent dose of any other beta blocker) for at least 4 weeks prior to study entry (participants who do not meet this criterion may be rescreened at the Investigator’s discretion). 6. In case of females, non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and nonpregnant & non-lactating females having a negative serum/urine pregnancy test.

ExclusionCriteria

Details

Patient will be excluded if any exclusion criteria listed below are met:
1. Has a mean seated SBP more than 180 mmHg or DBP more than 110 mmHg at Screening;
[Note: Mean seated BP is defined as the average of 3 seated BP measurements at any
single clinical site visit.]
2. Body mass index less than 40 kg^m2 at Screening;
3. Patients previously sensitive to any of the ingredients of the investigational products.
4. Patients with a known history of secondary or malignant hypertension.
5. Patients with EF less than 40 percent on 2D Echo.
6. New York Heart Association (NYHA) class IV Congestive Heart Failure.
7. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to
enrolment.
8. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary
artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior
to enrolment or is planned to undergo any of these procedures after randomization.
9. Any condition outside the renal and CV disease area, such as but not limited to
malignancy, with a life expectancy of less than 2 years based on investigator´s clinical
judgement.
10. Active malignancy requiring treatment at the time of visit 1.
11. Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT]less than 3x
the upper limit of normal [ULN]; or total bilirubin less than 2x ULN at time of enrolment).
12. Abnormal Serum Potassium (K+ equal to 3.5 to 5.1 mmol^L).
13. Abnormal TSH value at screening.
14. Renal Impairment (eGFR less than 60 mL^min per 1.73m2).
15. Type 1 Diabetes Mellitus or uncontrolled Type 2 DM (HbA1c more than 9.5 percent).
16. Patients otherwise judged to be inappropriate for inclusion in the study by the
investigator’s judgment.
17. Patients with known alcohol or drug abuse history.
18. Patients with known History of HIV, Hepatitis B and C.
19. Known history of blood-borne diseases.
20. Women of child-bearing potential (i.e., those who are not chemically or surgically
sterilized or who are not post-menopausal) who are not willing to use a medically
accepted method of contraception that is considered reliable in the judgment of the
investigator OR women who have a positive pregnancy test at enrolment or
randomization OR women who are breast-feeding.
21. Participation in another clinical study with an IP during the last month prior to
enrolment.
22. Inability of the patient, in the opinion of the investigator, to understand and/or comply
with IP, procedures and/or follow-up OR any conditions that, in the opinion of the
investigator, may render the patient unable to complete the study.

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Centralized

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Change in mean seated systolic blood pressure SeSBP	Baseline to week 12

Secondary Outcome

Outcome	TimePoints
Change in mean seated systolic Blood Pressure SeSBP	Baseline to Week 4 and 8
Change in mean seated diastolic Blood Pressure SeDBP	Baseline to week 4,8 and 12
Percentage of the patients achieved the target levels of clinical SeSBP	Week 4,8 and 12
Percentage of the patients achieved the target levels of clinical SeDBP	Week 4,8 and 12
Proportion of responders of dosing (Responder rate defined as the proportion of patients with decrease in diastolic BP at least 10 mmHg)	After 12 weeks

Target Sample Size

Total Sample Size="184"
Sample Size from India="184"
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 3

Date of First Enrollment (India)

30/04/2026

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
Modification(s)

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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

Windlas Biotech Limited is developing a fixed dose combination of Bisoprolol Fumarate 5 mg,Telmisartan 40mg and Chlorthalidone 12.5 mg as a therapeutic option for patients with uncontrolled essential hypertension and stable coronary artery disease (CAD).Hypertension in this population often requires multi-drug therapy and this FDC aims to simplify treatment while targeting key mechanisms involved in blood pressure elevation.The Investigational product is being compared with the approved reference combination containing metoprolol succinate ER 50mg ,Telmisartan 40 mg,and Chlorthalidone 12.5 mg .

The purpose of this Phase III study is to evaluate the efficacy ,safety and tolerability of the Bisoprolol based FDC versus the Metoprolol based standard of care in adult male and female patients aged 18-65 years with uncontrolled essential hypertension on dual therapy.A total of 202 patients will be enrolled and randomised in a 1 is to 1 ration ,with an 84 day treatment period and identical dosing conditions across both arms.

It is expected that the new Bisoprolol containing FDC will demonstrate comparable blood pressure lowering effects and a similar safety profile to the reference regimen. The study endpoints have been aligned with established clinical parameters and successful outcomes will offer an additional treatment option for patients and clinicians managing high risk hypertension.