| CTRI Number |
CTRI/2018/06/014458 [Registered on: 07/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Hypertension in India |
|
Scientific Title of Study
|
Hypertension Management in India: An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLHTN/02/2015,Version 1.0 Dated 25/Feb/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Suresh |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
27, Dept. of medical services, Race Course Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Suresh |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
27, Dept of medical services, Race Course Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
Senior Manager - Department of Medical Services |
| Affiliation |
Micro Labs Limited, Bangalore |
| Address |
27, Dept of medical services, Race Course Road,
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited,27, Race Course Road, Bangalore - 560001 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
27, Race Course Road, Bangalore - 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Muruganathan |
A G Hospital |
34, Dept. of medicine, AG hospital, K.P.N. Colony,
3rd Street, Tirupur – 641 601,
INDIA.
Coimbatore
TAMIL NADU |
9843060666
a.muruganathan@gmail.com |
| Dr C Venkat S Ram |
Apollo Hospitals |
Senior Consultant, Hypertension-And-Blood-Pressure-Management Clinic,
Apollo
Hospitals Director, Apollo
Institute for Blood Pressure
Management
Hyderabad
ANDHRA PRADESH |
7799806040
drram_v@apollohospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bangalore Ethics |
Approved |
| Bangalore Ethics |
Approved |
| NA |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed or known case of hypertensive patients on treatment.
The study subjects visited for a routine visit to their physician and were willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Those patients who required hospitalization for any cause were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Demographic variables,current treatment, |
Routine physician
visit at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| concomitant medications used, adherence to treatment |
Routine physician
visits at baseline |
|
|
Target Sample Size
|
Total Sample Size="3600"
Sample Size from India="3600"
Final Enrollment numbers achieved (Total)= "3814"
Final Enrollment numbers achieved (India)="3814" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2016 |
| Date of Study Completion (India) |
20/10/2017 |
| 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)
|
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)?
|
|
Brief Summary
|
Hypertension is one of the most common life threatening non-communicable diseases.The aim of this study was to pool data from across India and evaluate hypertension trends, socio demographic data, and clinician treatment preferences in the management of hypertension in Indian subjects. This was a cross sectional, multicentric, observational study conducted across India during the year 2016 - 2017. Centers were selected in this study from various cities and towns across India by convenience sampling.Despite the advances in the hypertension management and emphasis on patient education, our study shows that the hypertension continues to be a significant health burden. |