CTRI/2026/03/106183 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On:
13/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Clinical trial to evaluate the Mean change in SeSBP and Mean change in SeDBP from baseline to end of study giving Fixed dose combination of Bisoprolol 2.5/5 mg, Cilnidipine 10/10 mg and Telmisartan 40/40 mg tablet in patients with Stage II Hypertension with Stable CAD.
Scientific Title of Study
A Multicentric, Randomized, Double Blind, Parallel Group,
Comparative, Phase III Clinical Study to Evaluate the Efficacy,
Safety & Tolerability of FDC of Bisoprolol Fumarate plus
Telmisartan plus Cilnidipine Tablets versus FDC of Metoprolol
Succinate ER plus Telmisartan plus Cilnidipine Tablets in subjects
with Stage II Hypertension with Stable Coronary Artery Disease
(CAD) not controlled with dual therapy
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
PROTOCOL ID: MR/REV/2024-002, V. 02 Dated 31 Oct 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Sandeep Yadav
Designation
Managing Director
Affiliation
Manentia Research Pvt. Ltd
Address
CP-11, Phase III Ricco, Sitapura Industrial Area, Jaipur, Rajasthan - India 302022
Jaipur RAJASTHAN 302022 India
Phone
07290072455
Fax
Email
syadav@manentiaresearch.com
Details of Contact Person Scientific Query
Name
Mr Piyush Shukla
Designation
Senior Medical Writter
Affiliation
Manentia Research
Address
CP-11, Phase III Ricco, Sitapura Industrial Area, Jaipur, Rajasthan - India 302022
Jaipur RAJASTHAN 302022 India
Phone
9120401255
Fax
Email
crc@manentiaresearch.com
Details of Contact Person Public Query
Name
Mr Sandeep Yadav
Designation
Managing Director
Affiliation
Manentia Research Pvt. Ltd
Address
CP-11, Phase III Ricco, Sitapura Industrial Area, Jaipur, Rajasthan - India 302022
First floor, Room no 121, Opposite Adani CNG Gas
Station Near Motera BRTS
Bus Stop, Cross Roads,
Motera, Ahmedabad, Gujarat
380005 - India Ahmadabad GUJARAT
9687015463
drmaulitakapadia@gmail.com
Dr Abhishek Sachdeva
Motilal Nehra Medical College
Department of Cardiology, OPD Area, George Town Civil
Lines Prayagraj UP - India Pratapgarh UTTAR PRADESH
9833675823
sachdevadrabhishek@gmail.com
Dr Anand Bhat
Nano Hospital
Department of Cardiology, Ground Floor, 79, Sir, M
Visveswaraya road, near
Arekere Sai baba temple, Off
Banner ghatta road,
Bangalore- 560076 Bangalore KARNATAKA
9833675823
Sanand2023@emaii.com
Dr Rahul Sonawane
Saikrupa Hospital
OPD Dr. Rahul Sonawane, 1st Floor Saikrupa Hospital, Renuka Corner, Tapkir Chowk, Thergaon, Pune Pune MAHARASHTRA
FDC of Metoprolol Succinate ER 50 mg + Telmisartan 40 mg + Cilnidipine 10 mg Tablets
Oral Tablet, FDC of Metoprolol Succinate ER 50 mg + Telmisartan 40 mg + Cilnidipine 10 mg Tablets OD for 84 days
Intervention
Fixed-Dose Combination of Bisoprolol 2.5mg, Cilnidipine 10 mg and
Telmisartan 40 mg tablet
Oral tablet, Fixed-Dose Combination of Bisoprolol 2.5mg, Cilnidipine 10 mg and
Telmisartan 40 mg tablet - Every Morning OD for 84 days
Intervention
Fixed-Dose Combination of Bisoprolol 5 mg, Cilnidipine 10 mg and
Telmisartan 40 mg tablet
Oral tablet, Fixed-Dose Combination of Bisoprolol 5 mg, Cilnidipine 10 mg and
Telmisartan 40 mg tablet OD for 84 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Male or female subjects aged between 18 to 75 years.
2. Systolic BP (SBP) above or equal to 140 mmHg and diastolic BP (DBP) above or equal to 90 mmHg, despite adherence to a regimen of above or equal to 3 antihypertensive medications, including a diuretic, at optimal doses. Or, SBP above or equal to 160 mmHg and DBP above or equal to 100 mmHg, despite treatment with at least 2 antihypertensive agents.
3 Subjects who are willing to sign informed consent for participation in the study and
willing to adhere to all protocol procedures.
ExclusionCriteria
Details
1. Suspected hypersensitivity to either of the study medications or any of the ingredients of
the formulation.
2. Subjects with EF less than 40 percent on as per Simpson’s method on 2D Echo.
3. Subjects diagnosed with Malignant Hypertension.
4. Surgical or medical condition that, in the judgment of the Investigator, could interfere with
absorption, distribution, metabolism, or excretion of the drugs to be used.
5.Subjects with eGFR less than 60 mL per min per 1.73m2
Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid as per the discretion of the principal investigator.
6. Subjects with abnormal AST, ALT and alkaline phosphate with values more than 2.5
times the upper limit of normal, Bilirubin greater than 1.5 times upper limit of normal
(ULN) or a known case of hepatic cirrhosis.
7. Subjects with abnormal Thyroid Function Test (TSH).
Subjects with Type 1 Diabetes Mellitus or Diabetes Insipidus.
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.
8. Subjects with known case of symptomatic congestive heart failure, unstable angina
pectoris, myocardial infraction, percutaneous transluminal coronary angioplasty
(PTCA) in less than one year or coronary artery bypass graft (CABG) surgery in less
than one year, sinus node dysfunction, and any history of bradyarrhythmia and any
clinically significant cardiac arrhythmias.
Any known cardiac disease/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.)
Subjects with known case of Stroke.
9.Subject with clinical history of uncontrolled COPD or Bronchial Asthma.
-Subject with clinical history of Peripheral Vascular disease.
-Subjects with medical history of neoplastic disorders with expected survival less than 1
year.
-Subjects with known case of Epileptic seizures.
-Subjects with clinical history of bipolar disorder.
10.Concurrent participation in another clinical trial or any investigational therapy within 30
days prior to signing informed consent.
11. Currently taking prohibited concomitant medications(s) listed and inability or unwillingness to discontinue them for the entire study period.
12. Suspected inability or unwillingness to comply with the study procedures.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1.Mean change in SeSBP from baseline to end of study
2.Mean change in SeDBP from baseline to end of study
12 weeks
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving SeSBP less than 140 mmHg
12 Weeks
Proportion of patients achieving SeDBP less than 90 mmHg
12 Weeks
Mean change in SeDBP from baseline
4, 8 and 12 weeks
Mean change in SeSBP from baseline
4, 8 and 12 weeks
Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) between
baseline and end of study for 20% of patients
12 weeks
Target Sample Size
Total Sample Size="240" Sample Size from India="240" 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)
25/03/2026
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="0" Months="6" 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
According to recent data, cardiovascular diseases (CVDs) continue to be the leading cause of
death and disability in India.1The Global Burden of Disease Study 2019 estimates that CVDs are
responsible for a substantial proportion of mortality and disability in the country. In 2020,
approximately 2.6 million Indians were reported to die from coronary heart disease (CHD),
accounting for a significant percentage of all CVD deaths. Nearly half of these deaths occurred
in individuals aged 30-69 years. Indians experience CVD deaths at a younger age compared to
their counterparts in high-income countries. Recent estimates suggest that around 52% of CVD
deaths in India occur before the age of 70, compared to 23% in high-income countries,
highlighting a profound impact on the nation’s economy.2 Key contributing factors include the
rising prevalence of hypertension, dyslipidemia, diabetes, obesity, physical inactivity, and
tobacco use.
For the same Study Sponsor Revenbhel Healthacre Pvt. Ltd. has developed Fixed-dose combination of Bisoprolol 2.5/5 mg, Cilnidipine 10/10 mg and Telmisartan 40/40 mg tablet
which will be compared in the clinical trial against existing approved Fixed-dose combination of Metoprolol
ER 50 mg, Cilnidipine 10 mg and Telmisartan 40 mg tablet.