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CTRI Number  CTRI/2025/07/092103 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 25/02/2026
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 Clinical Trial to determine the efficacy and safety of Fixed-Dose Combination of Bisoprolol 5mg and Cilnidipine 10mg Tablet in patients with Essential Hypertension. 
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 5MG AND CILNIDIPINE 10MG TABLET VERSUS FIXED-DOSE COMBINATION OF METOPROLOL SUCCINATE ER 50MG AND CILNIDIPINE 10MG IN SUBJECTS WITH ESSENTIAL HYPERTENSION. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICS/UNI/2024-005 Version 1.0 Date 13 JUL 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Kartik Sahni 
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura

North West
DELHI
110034
India 
Phone  09868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kartik Sahni 
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura


DELHI
110034
India 
Phone  09868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Public Query  
Name  Mr Kartik Sahni 
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura


DELHI
110034
India 
Phone  09868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Source of Monetary or Material Support  
Unique Pharmaceutical Laboratories (a Division of J. B. Chemicals & Pharmaceuticals Ltd.) Plot No. A154-155, Road No. 25, Wagle Indl Estate-400604,Taluka: THN2, District: Thane-Zone1.  
 
Primary Sponsor  
Name  Unique Pharmaceutical Laboratories (a Division of J. B. Chemicals & Pharmaceuticals Ltd.) 
Address  Neelam Centre, B Wing, 4th Floor, Hind Cycle Road, Worli Mumbai (India) – 400030  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Unique Pharmaceutical Laboratories a Division of J B Chemicals Pharmaceuticals Ltd  Plot No. A154-155, Road No. 25, Wagle Indl Estate-400604,Taluka: THN2, District: Thane-Zone1.  
 
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 Richa Giri   GSVM Medical College   Department of Cardiology, Room No 01 Ground Floor Swaroop Nagar 208002 Kanpur Nagar UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH 		 8400331045

krricha227@gmail.com 
Dr MV Rama Mohan  PCRI Hospital Pvt.Ltd  PCRI Hospital, 1-53 Srinagar Padugupadu before NH-67, NTS 6ote, Srinagar, Nellore, Andhra Pradesh -524137, India
Nellore
ANDHRA PRADESH 		 9490463301

rammohanmddm@gmail.com 
Dr Himanshu Prajapati  Prajna Health Care  Prajna Healthcare 205-208 AAGAM AVENUE, NEAR ADANI CNG PUMP, SABARMATI, Chandkheda, Ahmedabad, Gujarat 380005
Ahmadabad
GUJARAT 		 9925075607

drhimanshupcr@gmail.com 
Dr Prashant Pawar  Signus Hospital  Department of Cardiology, Room No 04, 5th Floor, Atlanta Shoppers, Pathardi Phata, Pathardi Road Nashik, Maharashtra-422010, India.
Nashik
MAHARASHTRA 		 9623195719

drprashantpawar63@gmail.com  
Dr Laxmikant Goyal  SMS Medical Collegeand attached Hospital Jaipur  91/44 Patel Marg Near Rastogi Gas Agency, Mansarovar Pin Code-302020
Jaipur
RAJASTHAN 		 7597028028

drlkgoyal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee SMS Medical College and attached hospitals JLN Marg Jaipur Rajasthan-302004   Approved 
IEC Riddhi Medical Nursing Home   Approved 
PCRI ETHICS COMMITTEE PCRI Hospitals Private Limited C/O Shaikh Gayazuddin 02 PADUGUPADU KOVUR RURALS KOVUR NELLORE Nellore Andhra Pradesh - 524137 India  Approved 
Signus Hospital Ethics Committee, Signus Hospital   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 (FDC) of Bisoprolol 5mg and Cilnidipine 10mg tablet  One Tablet daily for 84 days 
Comparator Agent  Fixed-Dose Combination of Metoprolol Succinate ER 50mg and Cilnidipine 10mg Tablet  One Tablet daily for 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 with the background of stable coronary artery disease (CAD) with mean seated SBP ranging between 140-180 mmHg and or mean seated DBP ranging between 90-110 mmHg. Mean seated BP is defined as the average of 3 seated BP measurements at any screening or re-screening visit.
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
•Estimated glomerular filtration rate: less than 60 mL^min per 1.73 m2)
•Subjects with S. Creatinine values and S.BUN values more 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+ = 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 past history or present symptoms of Bradycardia [Pulse rate less than 60bpm] at 2 out of 3 measurements either at Screening or Randomization
4.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]
5.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 percent.
6.Subjects with a known history of secondary or malignant hypertension,
7.Subjects with LVEF less than 40 percent on 2D Echo at Screening or Randomization (previous reports of upto 8 weeks is acceptable),
8.Any known cardiac disease or disorder in which any of the study medication is contra-indicated (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.)
9.Subjects with known significant respiratory or liver or kidney or neurological diseases or uncontrolled diabetes
10.Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception
11.Subjects otherwise judged to be inappropriate for inclusion in the study by the investigator’s judgment
12.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
13.Subjects with known alcohol or drug abuse
14.Subjects with known History of HIV, Hepatitis B and Hepatitis C
15.Hemodynamically unstable subjects.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in mean seated systolic (SeSBP) blood pressure   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in mean seated diastolic (SeDBP) blood pressure   12 weeks  
Reduction in mean seated systolic (SeSBP) and seated diastolic (SeDBP) blood   4 weeks  
Reduction in mean seated systolic (SeSBP) and seated diastolic (SeDBP) blood pressure   8 weeks  
Percentage of the subjects achieving target clinical levels of mean seated systolic (SeSBP) blood pressure (target level: SeSBP less than 140 mm Hg)   4, 8 and 12 weeks 
Percentage of the subjects achieving target clinical levels of mean seated diastolic (SeDBP) blood pressure (target level: SeDBP less than 90 mm Hg)   4, 8 and 12 weeks 
Proportion of responders   12 weeks 
Reduction in mean heart rate compared to baseline  4, 8 and 12 weeks 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="214" 
Final Enrollment numbers achieved (Total)= "214"
Final Enrollment numbers achieved (India)="214" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) 08/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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  

Hypertension is a major individualistic risk factor for coronary artery disease, stroke, and renal failure. Reducing blood pressure (BP) below the target goal is important to prevent cardiovascular and cerebrovascular events. Various kinds of antihypertensive drugs such as diuretics, calcium channel blockers, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin-receptor blockers (ARBs) is usually used to lower BP effectively.

Monotherapy achieves optimal guideline recommended blood pressure targets only in 20–30 percent of patients with most hypertensive patients requiring a combination of two or more BP-lowering drugs.

The American Society of Hypertension, in a recent position paper, suggested starting with a combination therapy in patients with uncomplicated stage -1 HTN, in particular when one agent will improve the adverse effects profile of the other. European guidelines on HTN and the Joint National Committee 8 (JNC 8) guidelines recommend use of low dose combination therapy to initiate treatment even for those with mild hypertension.Even though CCBs have a linear dose-response curve, there is enhanced synergistic effect on BP reduction when additional antihypertensive agent such as beta-blocker is added to CCB therapy rather than simply doubling its dose. This combination therapy produces a more pronounced reduction in both systolic and diastolic BP.Bisoprolol Fumarate is the fumarate salt of a synthetic phenoxy-2-propanol-derived cardio-selective beta-1 adrenergic receptor antagonist with antihypertensive and potential cardioprotective activities. Devoid of intrinsic sympathomimetic activity, bisoprolol selectively and competitively binds to and blocks beta-1 adrenergic receptors in the heart, decreasing cardiac contractility and rate, reducing cardiac output, and lowering blood pressure.

 

Cilnidipine is a dihydropyridine calcium antagonist. Compared with other calcium antagonists, Cilnidipine can act on the N-type calcium channel that exists in sympathetic nerve endings besides acting on L-type calcium channels. Cilnidipine has been classified as a fourth-generation CCB based on its actions on sympathetic neurotransmitter release.

 

In India, Bisoprolol and Cilnidipine are already approved and marketed. Therefore, considering the unmet need for an FDC and based on regulatory requirement Unique Pharmaceutical Laboratories (a Division Of J. B. Chemicals & Pharmaceuticals Limited) proposes the present study be conducted to generate data on the Indian population. The study design is a multi-centre study to evaluate efficacy and safety of fixed-dose combination (FDC) of Bisoprolol 5mg and Cilnidipine 10mg tablet in subjects with mild to moderate hypertension. The purpose of the present study is to demonstrate that a fixed-dose combination (FDC) of Bisoprolol 5mg and Cilnidipine 10mg tablet is efficacious and safe in Indian subjects with regard to the routine clinical setting. 
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