CTRI/2025/02/080101 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On:
18/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Phase 3 Clinical Trial to Compare the Efficacy, Safety, and Tolerability of a Fixed Dose Combination of Telmisartan, Amlodipine, and Bisoprolol with Separate Administration of Telmisartan, Amlodipine, and Bisoprolol in Patients with Uncontrolled Hypertension and Stable Coronary Artery Disease
Scientific Title of Study
A Multicentric, Randomized, Double Blind, Double-Dummy, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets Versus Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NRPL/CT/0124/04 VERSION 02, DATED 30-SEP-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ujwala Salvi
Designation
CEO and Head of Clinical Operations
Affiliation
Nucleon Research Pvt. Ltd.
Address
Nucleon Research Private Limited, 2nd floor, Office No. 22, Hi Life Premises, P. M. Road, Santacruz West, Mumbai, Mumbai Suburban, Maharashtra, 400054 F58 Eternity Commercial Premises, Teen Hath Naka, Thane West 400054, India Mumbai MAHARASHTRA 400054 India
Phone
9920322733
Fax
Email
ujwala.salvi@nucleonresearch.com
Details of Contact Person Scientific Query
Name
Dr Ujwala Salvi
Designation
CEO and Head of Clinical Operations
Affiliation
Nucleon Research Pvt. Ltd.
Address
Nucleon Research Private Limited, 2nd floor, Office No. 22, Hi Life Premises, P. M. Road, Santacruz West, Mumbai, Mumbai Suburban, Maharashtra, 400054 F58 Eternity Commercial Premises, Teen Hath Naka, Thane West 400054, India
MAHARASHTRA 400054 India
Phone
9920322733
Fax
Email
ujwala.salvi@nucleonresearch.com
Details of Contact Person Public Query
Name
Dr Ujwala Salvi
Designation
CEO and Head of Clinical Operations
Affiliation
Nucleon Research Pvt. Ltd.
Address
Nucleon Research Private Limited, 2nd floor, Office No. 22, Hi Life Premises, P. M. Road, Santacruz West, Mumbai, Mumbai Suburban, Maharashtra, 400054 F58 Eternity Commercial Premises, Teen Hath Naka, Thane West 400054, India
MAHARASHTRA 400054 India
Phone
9920322733
Fax
Email
ujwala.salvi@nucleonresearch.com
Source of Monetary or Material Support
Ravenbhel Healthcare Pvt. Ltd.
16-17, EPIP, SIDCO, Kartholi,
Bari Brahamana, Samba- 181133, Jammu and Kashmir, India
Primary Sponsor
Name
Ravenbhel Healthcare Pvt. Ltd.
Address
16-17, EPIP, SIDCO, Kartholi, Bari Brahamana, Samba- 181133, Jammu and Kashmir, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 9
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sachin Hundekari
Eras Bharti Hospital
OPD room no. 2, Research Department, Ganesham Commercial, A building, 1st floor, near Govind Yashoda chowk, BRT link road, Pimple Saudagar Road, Pune, Maharashtra 411027 Pune MAHARASHTRA
7947144848
shundekari24@gmail.com
Dr Gunjan Malavia
Global Hospital
OPD room no. 2, Department of Cardiology, 4th Floor, Global Point, sarthana, Jakatnaka Surat, Gujarat 395006 Surat GUJARAT
9594467217
drgunjanmalaviacr@gmail.com
Dr Agarwal Ashish Kumar
JLN Medical College
OPD room, Department of Cardiology, Ground floor, Cardiology Building, Ajmer, Rajasthan 305001 Ajmer RAJASTHAN
9636016718
drashishagarwal1982@gmail.com
Dr Kiran Narang
Lion tarachand Bapa Hospital & Research Centre
Room no. 2, Department of Cardiology, 2nd floor, Shah Complex, Jain society, Sion (W), Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA
9702680576
dr.knarang@gmail.com
Dr Awadhesh Kumar Sharma
LPS Institute of Cardiology, GSVM Medical College
Room no. 10, Department of Cardiology, 3rd floor, Swaroop Nagar, Kanpur 208002 Kanpur Nagar UTTAR PRADESH
9501958808
awakush@gmail.com
Dr Subhashis Chakraborty
NRS Medical College and Hospital
VP room, Department of cardiology, 4th floor, UNB Building, Aacharya Jagdish Chandra Bose Road, Sealdah, Raja Bazar, Kolkata, West Bengal 700014 Kolkata WEST BENGAL
Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets
Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets,
one tablet once a day orally in the morning after breakfast around same time every day for 12 weeks.
FDC of Telmisartan 40 mg plus Amlodipine 5 mg plus Bisoprolol 2.5 mg tablets,
One tablet once a day orally in the morning after breakfast around same time every day for 12 weeks
FDC of Telmisartan 40 mg plus Amlodipine 5 mg plus Bisoprolol 5 mg tablets, one tablet once a day orally in the morning after breakfast around same time every day for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
Male or female subjects aged between 18 and 75 years.
Subjects of stable coronary artery disease.
Subjects with the history of uncontrolled essential hypertension with stable coronary artery disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of Amlodipine 5 mg plus Bisoprolol 5 mg Tablets for at least 4 weeks.
Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
ExclusionCriteria
Details
Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
Subjects with EF less than 40 percent on as per Simpsons method on 2D Echo.
Subjects diagnosed with Malignant Hypertension.
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.
Renal system:
Subjects with eGFR less than 60 mL/min/1.73m2
Subjects with abnormal lab values of Na+, K+, Mg++, Cl- and Uric acid.
Normal range: Na+ = 135-145 mEq/L, K+ = 3.5-5.0 mmol/L, Mg++ = 1.8-2.2 mg/dL, Cl-= 96-106 mEq/L and Uric acid 3.5-7.2 mg/dL.
Hepatic system:
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)/ Known hepatic cirrhosis).
Endocrine system:
Subjects with abnormal Thyroid Function Test [Normal range TSH = 0.4 to 4.0 mIU/L, T4 = 0.8 to 2.8 ng/dL, T3 = 100 to 200 nanograms per deciliter (ng/dL)].
Subjects with Type 1 Diabetes Mellitus / 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%.
Cardiovascular system:
Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infraction, percutaneous transluminal coronary angioplasty (PTCA) less than one year or coronary artery bypass graft (CABG) surgery 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 signific ant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
Subjects with known case of Stroke.
Other disease conditions:
Subject with clinical history of uncontrolled COPD/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.
Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
Suspected inability or unwillingness to comply with the study procedures.
Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
Pregnant woman or lactating mother.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Mean change in SeSBP from baseline to end of study.
Mean change in SeDBP from baseline to end of study.
Mean change in SeSBP from baseline to end of study (12 weeks).
Mean change in SeDBP from baseline to end of study (12 weeks).
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving SeSBP.
Proportion of patients achieving SeDBP.
Mean change in SeDBP from baseline to 4, 8 and 12 weeks.
Mean change in SeSBP from baseline to 4, 8 and 12 weeks.
Mean change in Ambulatory Blood Pressure.
Proportion of patients achieving SeSBP less than 140 mmHg (SeSBP responder) [Time frame: 12 weeks].
Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) [Time frame: 12 weeks].
Mean change in SeDBP from baseline to 4, 8 and 12 weeks.
Mean change in SeSBP from baseline to 4, 8 and 12 weeks.
Mean change in Ambulatory Blood Pressure (Mean 24 hours SBP and DBP) between baseline and end of study (12 weeks) for 20percent of patients.
Target Sample Size
Total Sample Size="306" Sample Size from India="306" Final Enrollment numbers achieved (Total)= "306" Final Enrollment numbers achieved (India)="306"
It is a Multicentric, Randomized, Double Blind, Double-Dummy, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets Versus Co-administration of Telmisartan 40 mg tablets, Amlodipine 5 mg tablets and Bisoprolol 5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
The primary objective of the study is to evaluate the efficacy of FDC of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets in subjects with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).
The secondary objective of the study is to evaluate the safety and tolerability of FDC of Telmisartan 40/40 mg plus Amlodipine 5/5 mg plus Bisoprolol 2.5/5 mg tablets in subject with Uncontrolled Essential Hypertension with stable coronary artery disease (CAD).