| CTRI Number |
CTRI/2015/01/005359 [Registered on: 06/01/2015] Trial Registered Prospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension |
|
Scientific Title of Study
|
A Multicentric, Prospective, Double blind, Randomized, Comparative Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/CARD/EFON/04/2011 Version No 1 Date 7th May 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girish Rajadhyaksha |
| Designation |
Principle Inestigator |
| Affiliation |
B. Y. L. Nair Charitable Hospital |
| Address |
Department of Medicine, 104 College Building, B. Y. L. Nair Charitable Hospital Mumbai-
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
girishraj63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office no 5119 D wing 5th floor Oberoi Garden Estates Chandivali Andheri east
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office no 5119 D wing 5th floor Oberoi Garden Estates Chandivali Andheri east
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office no 5119 D wing 5th Floor Oberoi Garden Estates Chandivali Andheri East |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Rajadhyaksha |
B. Y. L. Nair Charitable Hospital |
Department of medicine B. Y. L. Nair Charitable Hospital Mumbai-400008
Mumbai
MAHARASHTRA |
9821695349
girishraj63@gmail.com |
| Dr Nakul Sinha |
Divine Heart and Multispeciality Hospital, Lucknow |
Divine Heart and Multispeciality Hospital, Viraj Khand Institutional Area - 5, Gomti Nagar, Lucknow, Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
9919002760
sinha.nakul@gmail.com |
| Dr Mrunalini Motlag |
Indira Gandhi Government Medical College and Hospital |
Department of medicine Indira Gandhi Government Medical College and Hospital, Nagpur
Nagpur
MAHARASHTRA |
9960031486
drvandanabadar@yahoo.co.in |
| Dr Gouranga Sarkar |
Institute of Post Graduate Medical Education & Research , Kolkata |
Institute of Post Graduate Medical Education & Research
244, AJ.C. Bose Road, Kolkata- 700020.
Kolkata
WEST BENGAL |
9830165760
drgsmed@gmail.com |
| Dr Srinivas Reddy |
King George Hospital Andhra Medical College, Visakhapatnam |
Department of Medicine, King George Hospital,
Andhra Medical College, Visakhapatnam-530002, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH |
9703157774
bioexperts21@gmail.com |
| Dr Jitendra Kodilkar |
MVP Samajs Dr. Vasantrao Pawar Medical College, Hospital & Research Centre |
MVP Samajs Dr. Vasantrao Pawar Medical College, Hospital & Research Centre, department of medicine, Adgao, Nasik
Nashik
MAHARASHTRA |
9890314681
jitendrakodilkar@gmail.com |
| Dr Akula Siva Prasad |
Nizam Institute of Medical Sciences |
Panjagutta. Landmark Near GVK Mall
Punjagutta, Hyderabad
Andhra Pradesh, 500082
Hyderabad
ANDHRA PRADESH |
9989732529
akulasivaprasad@gmail.com |
| Dr Sanjay Sharma |
Omega Hospital, Mangalore |
Omega Hospital , Kankanady Bypass Road, Mahaveera Circle, Kankanady, Mangaluru, Karnataka 575002
Dakshina Kannada
KARNATAKA |
9910335590
sanju078@yahoo.co.uk |
| Dr BLN Prasad |
Rajiv Gandhi Institute of Medical Sciences |
Rajiv Gandhi Institute of Medical Sciences Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
9848211931
amcmedicine@hotmail.com |
| Dr Aditya Kapoor |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Cardiology Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow
Lucknow
UTTAR PRADESH |
5222668079
akapoor65@gmail.com |
| Dr Atul Patil |
Shree Saibaba Heart Institute and Research Centre, Nashik |
Shree Saibaba Heart Institute and Research Center,
Near Kalidas Kala Mandir,Shalimar, Nashik
Nashik
MAHARASHTRA |
7507305533
dratpatil@gmail.com |
| Dr Sharath Annam |
Sunshine Hospital |
Department of Cardiology Behind Paradise Hotel,Penderghast Road, Opposite Parsi Dharamsala, Secunderabad,pin-500003
Hyderabad
ANDHRA PRADESH |
91040646363
cardogh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. Vasantrao Pawar Medical College, Hospital & Research Centre |
Approved |
| Institutional Ethics Committee of Topiwala National Medical College and B.Y.L.Nair Charitable Hospital |
Approved |
| Institutional Ethics Committee Sunshine Hospital |
Approved |
| Institutional Ethics Committee, Divine Heart and Multispeciality Hospital, Lucknow |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, NIMS |
Approved |
| Institutional Ethics Committee, RIMS |
Approved |
| IPGME and R Research Oversight Committee |
Approved |
| Omega Ethics Committee |
Approved |
| Shree Saibaba Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amlodipine |
Amlodipine 5 mg orally o.d. for 4 weeks |
| Intervention |
Efonidipine |
Efonidipine 40 mg orally o.d. for 4 weeks |
|
|
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 as per Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII)
3.Patients with heart rate > 83 beats/min
4.Patients ready to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe hypertension with sitting systolic BP ≥ 180 mm Hg
2.Patients with history of stroke or myocardial infarction in the previous 6 months
3.Patients with congestive heart failure, sick sinus syndrome or sinus bradycardia (< 50 beats/min)
4.Patients with second- or third-degree atrioventricular block
5.Patients with documented hypersensitivity to dihydropyridine CCBs
6.Patients with hepatic disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper normal limit
7.Patients with renal disease with a serum creatinine concentration > 2.0 mg/dL
8.Patients with uncontrolled diabetes, (hemoglobin A1C > 9%), renal artery stenosis, or secondary hypertension
9.Pregnant women or nursing mothers
10.Females with child bearing potential (considerations relate to choice of contraception, planning for pregnancy and overall obstetric care during pregnancy)
11.Patients with history of alcohol dependence, alcohol abuse or drug abuse
12.Patients with history of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form)
13.Patients scheduled for surgery anytime during the study
14.Patient receiving some other drug during the study besides that in the protocol that could possibly alter the bio availability of the drug
15.The patient previously been participated in any other clinical trial within the last month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Proportion of patients achieving JNC VII target BP of 140/90 mm Hg by the end of treatment
•Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study)
|
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Proportion of patients achieving JNC VII target BP of 140/90 mm Hg after 2 weeks of therapy
|
28 Days |
•Proportion of patients achieving heart rate 83 beats per minute after 2 weeks of therapy
|
28 Days |
•Symptom relief: Defined as the absence of the clinical symptom of dyspnea and palpitations after 4 weeks of therapy
|
28 Days |
| Adverse events observed during the treatment period |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| 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
Modification(s)
|
Dewan B, Wani V. A Comparative Clinical Trial of Efonidipine and Amlodipine in Management of Stage-I Hypertension: A Randomized, Double-Blind Study in Indian Population. Journal of Advances in Medicine and Medical Research. 2018 Oct 12:1-2. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Multicentric, Prospective, Double blind, Randomized,
Comparative Clinical trial to evaluate the Efficacy and Tolerability of
Efonidipine
in the treatment of HypertensionThe aim of the study is to establish
non-inferiority of Efonidipine hydrochloride when compared with Amlodipine in
the management of hypertension
Primary Objective
- To assess the efficacy of Efonidipine
40 mg given once a day orally in alleviating symptoms of hypertension
Secondary Objective
- To
evaluate the safety & tolerability of the investigational drug in
Indian patients.
- To
evaluate patient compliance
|