| CTRI Number |
CTRI/2018/05/014303 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non-interventional study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to understand usage and effect of Azilsartan in Indian patients with high blood pressure |
|
Scientific Title of Study
|
A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and Effect of AZilsartan as MonothErapy or Add On TreatmeNt in Indian PaTients with Hypertension |
| Trial Acronym |
ZENITH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL1606003, Version-00, Dated 27/04/2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer I Dani |
| Designation |
Managing Director |
| Affiliation |
Life Care Institute of Medical Sciences and Research |
| Address |
Sardar Patel Statue Corner
Naranpura
Ahmedabad
380061
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940204020 |
| Fax |
|
| Email |
drsameerdani@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Jha |
| Designation |
Asst General Manager (Medical Services) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent House
Off Ashram Road
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000554 |
| Fax |
|
| Email |
pankajjha@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Altaf Makwana |
| Designation |
Asst Manager (Medical Services) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent House
Off Ashram Road
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000569 |
| Fax |
|
| Email |
altafmakwana@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd
Torrent House
Off Ashram Road
Ahmedabad
|
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Off. Ashram Road
Ahmedabad
380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer I Dani |
Life Care Institute of Medical Sciences and Research |
Sardar Patel Statue Corner
Naranpura
Ahmedabad
380061
Ahmadabad
GUJARAT |
40204020
drsameerdani@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to provide informed consent
2.Female or male patient aged 18 years or above
3.A treatment naive patient or a patient who are on treatment with other antihypertensive with grade 1 and 2 hypertension (SBP between 150 to 180)
4.Physician decides to prescribe azilsartan as a monotherapy or add-on
5.Patients must provide written consent to use personal and/or health data prior to the entry into the study
|
|
| ExclusionCriteria |
| Details |
1.Confirmed secondary hypertension
2.Patient taking a medicine acts upon RAAS e.g. ACEi or ARBs other than Azilsartan
3.Contraindications for azilsartan of respective approved local prescribing information.
4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent subject participation in the study
5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the mean change in clinic SBP and DBP levels from baseline to week 12 |
At baseline
At end of 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of Participants With Response. Response is defined as decrease of SBP ≥20 mm Hg or decrease of DBP ≥10 mm Hg.
2. Percentage of Participants who Achieve Target BP 140 mm Hg.Target BP is defined as SBP 140 mm Hg and DBP 90 mm Hg.
3.To understand usage pattern of azilsartan as monotherapy or add-on with other antihypertensive drugs
4.To assess adverse events during study duration |
At baseline
At end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet planned |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Non-Interventional, Multicenter, Prospective, Observational Study is to UNderstand the Effect of Azilsartan as monotherapy or add on treatment in Indian patients with hypertension (ZENITH Study). Total 1000 patients are planned from 20 different sites across India. The primary objective of the study is to assess the mean change in clinic SBP and DBP levels from baseline to week 12 in routine clinical practice treated with azilsartan either alone or add on therapy. Secondary objectives of study are (i) Percentage of participants with response [Time Frame: Baseline and week 12] (ii) Percentage of participants who achieve target BP <140 mm Hg (iii) To understand usage pattern of azilsartan as monotherapy or add-on with other antihypertensive drugs and (iv) to assess adverse events during study duration |