CTRI/2013/07/003793 [Registered on: 01/07/2013] Trial Registered Retrospectively
Last Modified On:
22/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Evaluation of safety and efficacy of Controlled release Hydrochlorothiazide in stage I Essential Hypertension
Scientific Title of Study
Comparative Evaluation of Safety and Efficacy of Hydrochlorothiazide CR with Hydrochlorothiazide and Chlorthalidone in patients with Stage I Essential Hypertension
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Ipca/HCCT/PIII-10,version no-Nil, version date-Nil
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
A-406, 4th floor, Shivalik Yash, Pallav cross Road, 132 ft ring road, Naranpura, Ahmedabad, Gujarat-380013 Ahmadabad GUJARAT
09426020154
kamalsharma1975@rediffmail.com
Dr S L Mathur
Dr.S.N.Medical College and MDM Hospital
Gyansar, A-5, Shastri nagar, Dalle khan ki Chakki Square,
near Krishna Medical, Pal Road, Jodhpur Jodhpur RAJASTHAN
09214409813
mathur_shyam@yahoo.com
Dr Arati Lalchandani
GSVM Medical College
GSVM Medical College and Lala Lajpat Rai Hospital, OPD Room No. 8, Swaroop Nagar,
Kanpur - 208002 Kanpur Nagar UTTAR PRADESH
09839870077
davelalchandani@gmail.com
Dr Atul Abhyankar
Heart First Cardiac and Vascular Centre
F-10, 3rd Floor, Next to D.Khushaldas jewellers, Sheron Plaza,Opp. Ambika Niketan Bus stop, Athwalines Road, Parle Point, Surat-395007, Gujarat Surat GUJARAT
Institute of Post Graduate
Medical Education and Research,
And SSKM Hospital,
4th Floor, Ronald Ross Building,
244, A. J. C. Bose Road,
Kolkata – 700020 Kolkata WEST BENGAL
09433230319
j_pal2004@rediffmail.com
Dr A G Ravishankar
K R Hospital
Department of Medicine Krishna Rajendra Hospital
Opp Mysore Medical College & Research Institute
Irwin Road Mysore – 570 001 Mysore KARNATAKA
Department of Medicine, 5th Floor, KEM Hospital, Rasta Peth, Sardar Moodliar Road,Pune, Maharashtra – 411011
Pune MAHARASHTRA
09422037431
dranilgodbole@rediffmail.com
Dr G Vijayaraghavan
Kerala Institute of Medical Science
Kerala Institute of Medical Science, P.B.No.1, Anayara P.O, Trivandrum- 695 029, Kerala, India Thiruvananthapuram KERALA
9847060855
kims.remedy@gmail.com
Dr B L N Prasad
King George Hospital
Unit-5,
Department of Medicine,
King George Hospital,Research Room (Medicine Block),
Beside Nizams Medicals,
Visakhapatnam-530002,A.P
Visakhapatnam ANDHRA PRADESH
09848211931
amcmedicine@hotmail.com
Dr Manish Agarwal
Medilink Hospital Research Centre, Ahmedabad
Medilink Hospital Research Center
Near Shyamal Char Rasta,
132 Ft. Ring Road, Satellite,
Ahmedabad – 380 015 Ahmadabad GUJARAT
9825443397
medilinkresearchcentre@yahoo.com
Dr S Selvamani
Meenakshi Mission Hospital and Research Centre
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai, Tamil Nadu- 625 107, India Madurai TAMIL NADU
Rajiv Gandhi Medical College and Chatrapati Shivaji Maharaj Hospital
Rajiv Gandhi Medical College and Chatrapati Shivaji Maharaj Hospital, Old Thane Belapur Road, Kalwa, Dist- Thane- 400 605, Maharashtra, India Thane MAHARASHTRA
9867936579
prasitapk@yahoo.co.in
Dr Sudhir Bhandari
SMS Medical College and attached Hospital, Jaipur
Department of Medicine,
SMS Medical College and attached Hospital,
Jawaharlal Nehru Marg,
Jaipur - 302004
Jaipur RAJASTHAN
9829078844
dr.bhandaricr@gmail.com
Dr Mrinal Kanti Das
The Calcutta Medical Research Institute
The Calcutta Medical Research Institute,
7/2, Diamond Harbour Road, Kolkata -700027, West Bengal, India Kolkata WEST BENGAL
Dose-Chlorthalidone-6.25mg,
Frequency-OD,
Mode of administration- Oral,
Duration-84 Days
Comparator Agent
Conventional Hydrochlorothiazide 12.5 mg
Dose-Conventional Hydrochlorothiazide-12.5 mg,
Frequency-OD,
Mode of administration- Oral,
Duration-84 Days
Intervention
Hydrochlorothiazide (controlled released)12.5 mg
Dose-Hydrochlorothiazide(controlled released-12.5 mg),
Frequency-OD,
Mode of administration- Oral,
Duration-84 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
i)patients with Systolic Blood Pressure-140-159mmHg and Diastolic Blood Pressure-90-99mmHg
ExclusionCriteria
Details
i)patients with secondary hypertension
ii) Patients with significant cardiovascular disease
iii)Patients with abnormal renal, liver function
iv)Patients currently uncontrolled on thiazide type diuretics
v)patients who have used another investigational agent/device within last 30 days prior to enrollment
vi) Patients taking concomitant medications known to alter the blood pressure or to affect the action of study drug
vii) Patients with known history of hypersensitivity to study drugs or other drugs of same chemical class
viii) Pregnant or lactating women or women of child-bearing potential not practicing contraception
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
To demonstrate comparative efficacy of Hydrochlorothiazide(controlled release)with chlorthalidone 6.25mg and also its superiority to hydrochlorothiazide 12.5mg with respect to change in 24 hr mean systolic and diastolic ambulatory blood pressure from baseline to week 4 and week 12
24 hr ABPM will be meausred at baseline, Week 4, and Week 12.
Secondary Outcome
Outcome
TimePoints
i)To compare change in mean office systolic and diastolic blood pressure at each visit from baseline
ii)To compare change in ambulatory daytime and nighttime mean systolic and diastolic blood pressure from baseline to week 4 and week 12
iii)To assess the safety and tolerabilty of test drugs compared to reference product
i)Office systolic and diastolic blood pressure will be measured at baseline, Day 7, Day 14, Day 28, Day 42, Day 56,Day 70,Day 84
ii)mean day-time and night-time ambulatory measurements at baseline, Week 4 and Week 12.
iii) Safety and tolerability of study medications throughout the study
Target Sample Size
Total Sample Size="213" Sample Size from India="213" Final Enrollment numbers achieved (Total)= "54" Final Enrollment numbers achieved (India)="54"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomized, comparative, double blind, double dummy, parallel group, multicentric study comparing efficacy and safety of Hydrochlorothiazide CR with Conventional Hydrochlorothiazide and Chlorthalidone in Patients with Stage 1 Essential Hypertension.The primary objective is to demonstrate that Hydrochlorothiazide CR 12.5 mg is as effective as Chlorthalidone 6.25 mg and is superior to Conventional Hydrochlorothiazide 12.5 mg with respect to change in 24-hr mean systolic (SBP) and diastolic (DBP) ambulatory BP from baseline to Week 4 and Week 12.The secondary objective is to compare the change in mean office SBP and DBP at each visit from baseline, to compare the change in ambulatory daytime and nighttime mean SBP and mean DBP from baseline to Week 4 and Week 12 and to assess the safety and tolerability of the test product as compared to the reference product