CTRI/2019/03/018167 [Registered on: 19/03/2019] Trial Registered Prospectively
Last Modified On:
16/05/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Phase IV study comparing Efonidipine 40mg Tablet to Cilnidipine 10 Mg Tablet In The Management Of Hypertension
Scientific Title of Study
A Multicentric, Prospective, Comparative, Randomized Phase-IV Study For Evaluation Of Efficacy And Safety Of Efonidipine 40mg Tablet In Comparison to Cilnidipine 10 Mg Tablet In The Management Of Hypertension
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ZUV/EFFECT/HQ-04/2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bhupesh Dewan
Designation
Director- Medical Services
Affiliation
Zuventus Healthcare Limited
Address
5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E)
Mumbai MAHARASHTRA 400 072 India
Phone
022-30610000
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Scientific Query
Name
Dr Bhupesh Dewan
Designation
Director- Medical Services
Affiliation
Zuventus Healthcare Limited
Address
5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E)
Mumbai MAHARASHTRA 400 072 India
Phone
022-30610000
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Public Query
Name
Dr Bhupesh Dewan
Designation
Director- Medical Services
Affiliation
Zuventus Healthcare Limited
Address
5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E)
Ground Floor, Plot No. 86, Opp. Jog School, Off Karve Road, Mayur Colony, Kothrud Pune MAHARASHTRA
9822098670
dialysis97@gmail.com
Dr Arun B Shah
Bharatiya Arogya Nidhi Hospital
1st floor, Dialysis unit, N.S. Road Number 13, Chand Society, Juhu,Vile Parle West Mumbai MAHARASHTRA
9821133935
drarunshah56@gmail.com
Dr C M Nagesh
Cardea clinic
"Jaiganesh", No 321, 1st floor, 36th A cross, 7th Main, 5th Block Jayanagar, Near Good Shepherd School Bangalore KARNATAKA
9742263936
drnageshcm@yahoo.com
Dr Vijay Alagappan
Dr. Vijay Alagappan Clinic
43/91, 7th Ave, Indira Colony, Ashok Nagar Chennai TAMIL NADU
98844443526
vijrus@hotmail.com
Dr Vijay Mandora
Dr. Vijay Mandoras Clinic
501-B Panna Chambers, Ghorpade Peth, Swargate Pune MAHARASHTRA
9422037617
mandoravp@yahoo.co.in
Dr N Krishna Reddy
Durgabai Deshmukh Hospital
1-9-27, Osmania University Rd, Vidya Nagar, Adikmet Hyderabad TELANGANA
9849001616
nkreddy61@gmail.com
Dr Krishna Kumar
Excel Hospital
Dept of Cardiology, 1-5-56/29,
Old Alwal Road, Banda Basti, Alwal,
Secunderabad, Telangana- 500010
Hyderabad TELANGANA
7731030321
doctorresearch1212@gmail.com
Dr Gouranga Sarkar
Health Point Hospital
Room No. 12, 1st floor, Department of General Medicine, Health Point Hospital, 21, Prannath Pandit Street (Opp. Lansdown Padmapukur), Kolkata – 700025, West Bengal Kolkata WEST BENGAL
9830165760
drgsmed@gmail.com
Dr Chetan Shah
Heart Rhythm Clinic
3rd Floor, Manu Market, Mahatma Gandhi Road, Ghatkopar West Mumbai MAHARASHTRA
9821115485
chetanshah@hotmail.com
Dr Manoj Gupta
Indopath Clinical Pvt. Ltd.
1st floor, Indopath Clinical Pvt. Ltd., 87, Chowringhee Road, Near Rabindra Sadan, Metro Gate No. 4, Kolkata – 700020, West Bengal Kolkata WEST BENGAL
9599038676
manojsrmc@gmail.com
Dr Amit Bhaskar
Janta Hospital
Room no. 04, Clinical Research Department, 1st Floor, Janta Hospital, Near Water Head tank, Amara-Akhari by pass, Chunar Road, Varanasi- 221011, Uttar Pradesh Varanasi UTTAR PRADESH
9580210470
dramitbhaskar@gmail.com
Dr Arun K N
Kidney Care
Department of Nephrology, #10, Opp. Jain Hospital, Opposite Millers Tank Bund Road, Kaveri Appa Layout, Millers Road., Bangalore Bangalore KARNATAKA
9844056001
drarunkn@yahoo.co.in
Dr L Meenakshisundaram
L. M. Medical Centre
50/108, Goudiya Mutt Street, Royapettah Chennai TAMIL NADU
18, 3rd Main Road, Seetammal Colony, MIG Colony, Alwarpet Chennai TAMIL NADU
9840044287
kpshamsuddeen@gmail.com
Dr Sanjeev Kumar A Hiremath
Ragavs Diagnostic & Research Centre Pvt.Ltd.
10/804-1, Patalamma Temple Road, Anebande Road, Jayanagar East Bangalore KARNATAKA
9844137996
sanjeevhiremath@rediffmail.com
Dr Mahesh Swamy
Ramya Hospital
Dept of Medicine, Room No.103,
H: No. 2-96/1, Old Bowenpally Cross Road,
Secunderabad, Telangana- 500011
Hyderabad TELANGANA
9666911868
doctorteam3@gmail.com
Dr Chaitanya Reddy
Ray’s Diagnostics & Diabetes Centre
Plot No. 1-5-108/3/1, Near St. Michel School Road, Jannobanda, Old Alwal, Secunderabad, Telangana 500010 Hyderabad TELANGANA
9948027129
reddychaitanya543@gmail.com
Dr Jayprakash Rathi
Remedy Hospital
Ground Floor, Medicine OPD, Ramanand Complex,
Pune-Solapur Road, Near Janseva Bank & Hotel Krishna Chaya Pune MAHARASHTRA
02026999186
remedyhospitalpune@gmail.com
Dr Rajkumar Nikalje
Skinovate Laser & Cosmetic Clinic
Office No. 302 and 303, Third Floor, Royal Avenue, Survey No.I8, Hissa No.l1/6, Next to Hotel Shivar Garden, Pimple Saudagar, Rahatani, Taluka-Haveli Pune MAHARASHTRA
9028560535
Nikaljeraj80@gmail.com
Dr Srinivas Kulkarni
Sri Clinic
Shop No.3-4, 206/2, Kachiguda Station Rd, Lingampally, Kachiguda Hyderabad TELANGANA
9849333914
srinivaskulkarni_dr@rediffmail.com
Dr G Madanamohan
Sri Vaishnavi Diabeties Medical Centre
No.408, Poonamallee High Rd, Karthikeyan Nagar, Maduravoyal Chennai TAMIL NADU
9444340651
no2snore@gmail.com
Dr Lily Rodrigues
Surakshaka Multi-Speciality And Diabetes Hospitals
Room No.406, M.I.G 218, KPHB Colony Main Road, Landmark: Opposite KPHB Colony Metro Station
KPHB Hyderabad TELANGANA
9704799955
drrlily@gmail.com
Dr Ashwani Mehta
The Heart Clinic
No. 13, Double Storey Market, New Rajinder Nagar New Delhi DELHI
One tablet of 10 mg to be taken orally once a day for 90 days
Intervention
Efonidipine 40mg tablet
One tablet of 40 mg to be taken orally once a day for 90 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients aged 18 to 65 years
2. Patients with Stage 1 hypertension (SBP/DBP: 140-159/90-99 mmHg) or stage II(SBP/DBP: ≥160/100 mmHg) hypertension as per Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII)
2.1. Subgroup of patients with stage I hypertension: Patients diagnosed with Stage I hypertension (JNC VII)
2.2. Subgroup of patients with renal impairment: Stage I or stage II hypertensive patients (JNC VII) diagnosed with renal impairment who do not need dialysis or replacement therapy
2.3. Subgroup of patients with Diabetes: Stage I or stage II hypertensive (JNC VII) patients with diabetes
3. Patients willing to sign informed consent
ExclusionCriteria
Details
1. Patient with cerebrovascular disease in the previous 3 months.
2. Patients with congestive heart failure, chronic arrhythmia, sick sinus syndrome or sinus bradycardia (< 50 beats/min)
3. Patients with second- or third-degree atrioventricular block
4. Patients with documented hypersensitivity to dihydropyridine calcium channel blockers or Efonidipine HCl
5. Women who are pregnant or breast feeding
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Mean change in sitting Systolic Blood Pressure (SBP)
2. Mean change in sitting Diastolic Blood Pressure (DBP)
From Baseline(Day 0) to Day 90
Secondary Outcome
Outcome
TimePoints
1. Changes in proteinuria
2. Mean Change in Systolic Blood Pressure (SBP) From Baseline (Day 0) to Day 30 and 60
3. Mean Change in Diastolic Blood Pressure (DBP)
4. Number of subjects achieving target BP as per JNC VIII guidelines for Hypertension.
5. Number of subjects reporting incidences of adverse events or Serious Adverse events
1. From baseline (Day 0) after Day 90
2. From Baseline (Day 0) to Day 30 and 60
3. From Baseline (Day 0) to Day 30 and 60
4. On day 90
5. Throughout study duration
Target Sample Size
Total Sample Size="1200" Sample Size from India="1200" Final Enrollment numbers achieved (Total)= "1200" Final Enrollment numbers achieved (India)="1200"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Study Title: A multicentric, prospective, comparative, randomized phase IV study for evaluation of efficacy and safety of efonidipine 40 mg tablet in comparison to cilnidipine 10 mg tablet in the management of hypertension.
Study Objective: To evaluate the efiicacy and safety of efonidipine 40 mg in comparison with clinidipine 10 mg tablets.
Primary Objective: To assess and compare the efficacy of efonidipine 40 mg and cilnidipine 10 mg in blood pressure reduction.
Secondary Objective:
a) To evaluate and compare the effect of the two treatment groups on reduction of proteinuria.
b) To evaluate the number of patients achieving target BP as per JNC VIII guideline.
c) To evaluate and compare the safety of the two treatments over a period of 3 months.
Estimated Sample Size: 1000 patients.A drop out rate of 20%shall be considered, therefore, total of 1200 patients may be recruited.
Treatment: Efonidipine and Cilnidipine groups will be randomised in 3:1 ratio.
Study endpoints:
Primary outcomes:
1. Mean change in sitting systolic blood pressure from day 0 to day 90.
2. Mean change in sitting diastolic blood pressure from day 0 to day 90.
Secondary outcomes:
1. Changes in proteinuria from day 0 after day 90 of the treatment.
2. Mean change in systolic blood pressure from day 0 to day 30 and day 60.
3. Mean change in diastolic blood pressure from day o to day 30 and day 60.
4. Number of patients achieving target blood pressure as per JNC VIII guidelines for Hypertension.
5. Number of patients reporting incidences of adverse events or Serious adverse events