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CTRI Number  CTRI/2024/11/077154 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized, double-blind, parallel-group and active controlled clinical study to assess the efficacy and safety of FDC of Bisoprolol and Cilnidipine tablet versus FDC of Metoprolol Succinate ER and Cilnidipine in treating Hypertension associated with coronary artery disease 
Scientific Title of Study   A multicenter, randomized, double-blind, parallel-group, comparative, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Cilnidipine 10mg in subjects with Essential Hypertension associated with coronary artery disease (CAD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICS/WIN/2022-007 Version 3.0 dated 28 Nov 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neel Lahoti 
Designation  Head CRO 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos 101 to 104 Sai Chambers 302 Opposite Bajaj showroom Old Mumbai Pune Highway Wakadewadi Shivajinagar

Pune
MAHARASHTRA
411003
India 
Phone  9028000444  
Fax    
Email  neel@synergenbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Daberal 
Designation  Head Medical Regulatory Affairs 
Affiliation  Windlas Biotech Limited 
Address  M/s. Windlas Biotech Limited 40/1, Mohabewala Industrial Area, Dehradun – 248 110 Uttarakhand, India

Dehradun
UTTARANCHAL
248110
India 
Phone  01356608000  
Fax    
Email  Prashant@windlasbiotech.com  
 
Details of Contact Person
Public Query  
Name  Mr Umakant Ghodke 
Designation  Head CT 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos 101 to 104 Sai Chambers 302 Opposite Bajaj showroom Old Mumbai Pune Highway Wakadewadi Shivajinagar

Pune
MAHARASHTRA
411003
India 
Phone  9960598942  
Fax    
Email  Umakant.Ghodke@synergenbio.com  
 
Source of Monetary or Material Support  
M/s. Windlas Biotech Limited 40/1, Mohabewala Industrial Area, Dehradun 248 110 Uttarakhand, India 
 
Primary Sponsor  
Name  Windlas Biotech Limited 
Address  M/s. Windlas Biotech Limited 40/1, Mohabewala Industrial Area, Dehradun – 248 110 Uttarakhand, India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suhas Kalashetti  Shri Samarth Hospital  Shri Samarth Hospital 227, Omkar Apartment, Viththalrao Kangle Road, Karande Chowk Pune 411028
Pune
MAHARASHTRA 		 8805387387

skalashetti@yahoo.com 
Dr Amit Bhate   Bhate Hospital   CTS No. 4830/13/14, First floor, Dr B R Ambedkar Rd, opp. Civil District Hospital, Belagavi, Karnataka 590002, India, Belgaum.
Belgaum
KARNATAKA 		 9695237796

amitbhate85@gmail.com 
Dr BUDHIA ANUP KUMAR   Hitech Medical College and Hospital  Department of General Medicine, Ground Floor, Hitech Medical College and Hospital, Health Park, Pandra, Rasulgargh, Bhubaneswar, Odisha-751025
Khordha
ORISSA 		 7008723962

dr.anupkumarbudhia@yahoo.com 
Dr Rohit Kale  IVAA Multi Speciality Hospital  IVAA Multi Speciality Hospital, 208, Yash-101 Commercial Complex, Teerth Town Road, Baner Annex, Sus, Pune-411021
Pune
MAHARASHTRA 		 9970505087

dr.rohitkale@ivaahospital.com 
Dr Prabhat Kumar Agrawal  S N Medical College Agra  Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH 		 9319250485

ppagrawal120@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
INDEPENDENT RESEARCH ETHICS COMMITTEE PUNE   Approved 
Institutional Ethics Committee BIMS  Approved 
Institutional Ethics Committee Hi Tech Medical College and Hospital  Approved 
Institutional Ethics Committee S.N Medical College, Agra  Approved 
Institutional Ethics Committee Shree Samarth Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet  Subjects will be instructed to take one tablet of the test in morning one (1) hour before or two to three (2-3) hours after breakfast daily for entire duration of the study, i.e, 84 days. 
Comparator Agent  Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Cilnidipine 10mg   Subjects will be instructed to take one tablet of the comparator in morning one (1) hour before or two to three (2-3) hours after breakfast daily for entire duration of the study, i.e, 84 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female participants with age 18 years to 65 years (both inclusive) at the time of screening
2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol
3. Subjects diagnosed with Essential Hypertension associated with stable coronary artery disease (CAD) with SBP ranging between 140-180 mmHg and/or DBP ranging between 90-110 mmHg
4. Females of non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females 
 
ExclusionCriteria 
Details  1. Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or angiotensin receptor blockers
2. Subjects with clinically significant renal disorders are as below
Estimated glomerular filtration rate is less than 60 mL per min per 1.73 m2)
Subjects with S. Creatinine values and S.BUN values greater than equal to 1.5 times the upper limit of normal
Subjects with abnormal lab values of Na+ K+ Mg++ and Uric acid. Normal range: Na+ is equal to 135 to 145 mEq per L and K+ is equal to 3.5 to 5.0 mmol per L, Mg++ is equal to 1.8 to 2.2 mg per dL and Uric acid 3.5 to 7.2 mg per dL
3. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease abnormal Liver Function Test with values more than 2.5 times the upper limit of normal
4. Subjects with clinically Endocrine system disorders are
Subjects with abnormal Thyroid Function Test (TSH)
Subjects with Type 1 Diabetes Mellitus
Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8 percent
5. Subjects with a known history of secondary or malignant hypertension.
6. Subjects with EF less than 40 percent as per Simpson’s method on 2D Echo.
7. Any known cardiac disease or disorder in which any of the study medication is contraindicated
(e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
8. Subjects with known significant respiratory or liver or kidney or neurological diseases or uncontrolled diabetes,
9. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception,
10. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator’s judgment.
11. Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic or pharmacodynamic profile of the study drug,
12. Subjects with known alcohol or drug abuse.
13. Subjects with known History of HIV, Hepatitis B and Hepatitis C. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean reduction in systolic and diastolic blood pressure measured in sitting position  From Baseline to week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline
2.Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeSBP less than 140 mm Hg)
3.Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeDBP less than 90 mm Hg)
4.Proportion of responders after 12 weeks of dosing (Responder rate defined as the proportion of subjects with decrease in diastolic BP by at least 10 mmHg)
5.Reduction in mean heart rate compared to baseline
 		 1.Compared to baseline after 4 and 8 weeks
2.After 4, 8 and 12 weeks
3.After 4, 8 and 12 weeks
4.After 4, 8 and 12 weeks
5.Proportion of responders after 12 weeks of dosing
6.After 4, 8 and 12 weeks 
 
Target Sample Size
Modification(s)  		 Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/12/2024 
Date of Study Completion (India) 23/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Protocol Title : A multicenter, randomized, double-blind, parallel-group, comparative, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Cilnidipine 10mg in subjects with Essential Hypertension associated with coronary artery disease (CAD).

Study Objectives:

Primary Objectives : To evaluate and compare the efficacy of Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Cilnidipine 10 mg tablets in subjects with essential hypertension associated with coronary artery disease (CAD).

Secondary Objective : To evaluate the safety of Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet versus Fixed-Dose Combination of Metoprolol Succinate ER 50mg and Cilnidipine10 mg tablets in subjects with essential hypertension associated with coronary artery disease (CAD).

Investigational Product:

Test Arm: Treatment Arm 1: Fixed-Dose Combination (FDC) of Bisoprolol 5 mg and Cilnidipine 10 mg tablet (n=115)  
Route of Administration: For oral use to take one tablet of test in morning (one hour before or two to three (2-3) hours after breakfast)

Reference Arm: Treatment Arm 2: Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Cilnidipine 10 mg (n=115)
Route of Administration: For oral use to take one tablet of reference in morning (one hour before or two to three (2-3) hours after breakfast)

Study Duration:
Subject participation will be for 12 weeks. (84 Days)

Inclusion Criteria :
1. Male or female participants with age 18 years to 65 years (both inclusive) at the time of screening.
2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol.
3. Subjects diagnosed with Essential Hypertension associated with stable coronary artery disease (CAD) with SBP ranging between 140-180 mmHg and/or DBP ranging between 90-110 mmHg (Stable CAD is defined as a patient who is apparently stable with no history of chest pain or any sign/symptom of chest discomfort and no alteration in the treatment taken for the past 3 months.)
4. Females of non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females.

Exclusion Criteria :
1. Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or angiotensin receptor blockers,
2. Subjects with clinically significant renal disorders:
    Estimated glomerular filtration rate: <60 mL/min per 1.73 m2)
    Subjects with S. Creatinine values and S.BUN values ≥ 1.5 times the  upper limit of normal.
    Subjects with abnormal lab values of Na+, K+, Mg++ and Uric acid. [Normal range: Na+ = 135-145 mEq/L, K+ = 3.5 – 5.0 mmol/L, Mg++ = 1.8-2.2 mg/dL and Uric acid 3.5 – 7.2 mg/dL]
3. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease [abnormal Liver Function Test with values more than 2.5 times the upper limit of normal]
4. Subjects with clinically Endocrine system disorders:
    Subjects with abnormal Thyroid Function Test (TSH).
    Subjects with Type 1 Diabetes Mellitus.
    Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
5. Subjects with a known history of secondary or malignant hypertension.
6. Subjects with EF <40% as per Simpson’s method on 2D Echo.
7. Any known cardiac disease/disorder in which any of the study medication is contraindicated (e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
8. Subjects with known significant respiratory/liver/kidney/neurological diseases/ uncontrolled diabetes,
9. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception,
10. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator’s judgment.
11. Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug,
12. Subjects with known alcohol or drug abuse.
13. Subjects with known History of HIV, Hepatitis B and Hepatitis C.

Study Schedule: 

Visit 1: Screening Visit (Day -3 to Day 0)
Visit 2: Baseline / Randomization Visit (Day 1)
Visit 3: Treatment Follow-up Visit 1 (Day 28 ± 1 Days)
Visit 4: Treatment Follow-up Visit 2 (Day 56 + 2 Days)
Visit 5: End of Study Visit (Day 84 ± 2 Days)
Visit 6: Unscheduled Visit / Early Discontinuation Visit

Primary efficacy endpoint will be:
Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline (12 weeks)

Secondary efficacy endpoints include:
Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline (After 4 and 8 weeks)
Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeSBP < 140 mm Hg) (After 4, 8 and 12 weeks).
Percentage of the subjects achieved the target levels of clinical BP among hypertensive subjects (target level: SeDBP < 90 mm Hg) (After 4, 8 and 12 weeks).
Proportion of responders after 12 weeks of dosing (Responder rate defined as the proportion of subjects with decrease in diastolic BP by at least 10 mmHg).
Reduction in mean heart rate compared to baseline (After 4, 8 and 12 weeks)

 
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