FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044031 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 19/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A multicentric randomized comparative phase III clinical study of FDC of Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets Versus FDC of Amlodipine 5 mg plus Telmisartan 40 mg tablets in subjects with stage 2 hypertension 
Scientific Title of Study   A multicentric randomized double blind parallel group two arm comparative phase III clinical study to evaluate the efficacy safety and tolerability of FDC of Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets Versus FDC of Amlodipine 5 mg plus Telmisartan 40 mg tablets in subjects with stage 2 hypertension 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Id:MCR/CT/0221/01 Version No:01 Dated:23-06-2022  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishal Shah 
Designation  Principal Investigator 
Affiliation  Lifeline Multispeciality Hospital 
Address  Vishal Complex, S. V. Rd, Opposite N L High School, Malad West, Mumbai, Maharashtra 400095

Thane
MAHARASHTRA
400095
India 
Phone  09833803296  
Fax    
Email  vshah8962@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Shravan Kumar Singh 
Designation  General Manager(Drug Regulatory and Corporate Affairs) 
Affiliation  Mascot Health Series Pvt. Ltd. 
Address  Mascot Health Series Pvt. Ltd. 75, 76, 77, J Block DDA Market VikasPuri, New Delhi-110018

New Delhi
DELHI
110018
India 
Phone  8587875225  
Fax    
Email  gm.ra@mascothealth.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravindra Mote 
Designation  Director 
Affiliation  Mediclin Clinical Research 
Address  Mediclin Clinical Research, Fourth Floor, Ambika Industries, Penkar Pada, Opposite Thakur Mall, Mira Road (E), Thane-401107, India Mumbai (Suburban)

Thane
MAHARASHTRA
401107
India 
Phone  8888884024   
Fax    
Email  ravindra.mote@mediclincr.com  
 
Source of Monetary or Material Support  
Mascot Health Series PVT. Ltd. Plot No. 79-80, Sector 6A, IIE SIDCUL, Haridwar, Uttarakhand-249403 
 
Primary Sponsor  
Name  Mascot Health Series PVT Ltd 
Address  Plot No. 79-80, Sector 6A, IIE SIDCUL, Haridwar, Uttarakhand-249403 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishal Shah  Lifeline Multispeciality Hospital  Vishal Complex, S. V. Rd, Opposite N L High School, Malad West, Mumbai, Maharashtra 400095
Thane
MAHARASHTRA 		 09833803296

vshah8962@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES  Approved 
ETHICS COMMITTEE BRIJ MEDICAL CENTER  Approved 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR   Approved 
ETHICS COMMITTEE HB SPECIALITY HOSPITAL  Approved 
ETHICS COMMITTEE MOTILAL NEHRU MEDICAL COLLEGE  Approved 
HEALTH POINT ETHICS COMMITTEE  Approved 
INSTITUTIONAL ETHICS COMMITTE AATMAN HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE AND GOVERNMENT GENERAL HOSPITAL  Approved 
SHAH LIFELINE HOSPITAL AND HEART INSTITUTE ETHICS COMMITTEE  Approved 
SHAH LIFELINE HOSPITAL AND HEART INSTITUTE ETHICS COMMITTEE  Approved 
SHAH LIFELINE HOSPITAL AND HEART INSTITUTE ETHICS COMMITTEE  Approved 
SHAH LIFELINE HOSPITAL AND HEART INSTITUTE 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 
Comparator Agent  Amlodipine 5mg plus Telmisartan 40 mg   Amlodipine 5mg plus Telmisartan 40 mg orally once daily after breakfast for 84 days 
Intervention  Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets  Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets orlly once daily after breakfast for 84 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or Female subjects of age 18 to 65 years (both inclusive).
2. Treatment-Naïve subjects diagnosed with Stage 2 Hypertension having mean SBP of ≥160 to ≤180 mmHg and mean DBP ≥100 to ≤110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
3. Subjects with the ability to understand and provide a written informed consent form, which must have been obtained before the screening.
4. Subjects willing to comply with the protocol requirements. 
 
ExclusionCriteria 
Details  1. Suspected hypersensitivity to either the study medications or any of the formulation ingredients.
2. Subjects with a medical history of oncological conditions for the last 2 years.
3. Subjects with known cases of Epileptic seizures, clinical history of bipolar disorder i.e. who are taking lithium.
4. Patients suspected to be addicted to alcohol or drug abuse or with severe complications that would make the condition more complicated were assessed by the investigator.
5. Subject having any disease/ abnormalities as follow,
Cardiovascular system:
• Subject with unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, and any clinically significant cardiac arrhythmias.
• Subjects with known cases of Secondary or Malignant Hypertension.
• Subjects with known cases of symptomatic congestive heart failure, severe aortic stenosis.
Endocrine system:
• Subjects with abnormal Thyroid Function Test (TSH) [Normal range is 0.45 to 4.5 mIU/mL].
• 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 an HbA1c value greater than 8%.
Renal system:
• Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening [Normal range 3.5 to 5.5 mEq/L.
• Subjects with hyponatraemia as per blood biochemistry results at screening [Normal range 135 to 145 mEq/L].
• Subjects with abnormal Renal Function Test (RFT) [Serum Creatinine Normal range 0.6 to 1.3 mg/dL] & [BUN Normal range 7 to 20 mg/dL].
• Subjects with abnormal eGFR (<60 mL/min/1.73 m2).
• Subjects with known cases of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant, or with only one functioning kidney.
Hepatic system:
• Subjects with abnormal Liver Function Tests with values more than 2.5 times the upper limit of normal.
6. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
7. Females who are not ready to use acceptable contraceptive methods during study.
8. Concurrent participation in another clinical trial or any investigational therapy within 30 days before signing informed consent.
9. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
10. Suspected inability or unwillingness to comply with the study procedures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. Change from baseline in mean sitting SBP to the end of study (12 weeks). [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point].
2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)). 		 1. Change from baseline in mean sitting SBP to the end of study (12 weeks). [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point].
2. The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from baseline in mean sitting DBP at the end of study (12 weeks). [For subjects who are discontinued due to lack of efficacy last DBP reading at the time of discontinuation will be considered as end point].
2. Mean change in Ambulatory Blood Pressure (12 weeks) (Approximately for 25% of study population).
3. The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and Changes in laboratory values. 		 Change from baseline in mean sitting DBP at the end of study (12 weeks). 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/07/2022 
Date of Study Completion (India) 05/12/2022 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of FDC of Azelnidipine 16 mg plus Telmisartan 40 mg Film Coated Tablets Versus FDC of Amlodipine 5mg + Telmisartan 40 mg tablets in Subjects with Stage 2 Hypertension. 
Close