| CTRI Number |
CTRI/2025/12/099604 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare olmesartan and azilsartan in reducing high blood pressure patients |
|
Scientific Title of Study
|
A Comparative study of efficacy, safety and tolerance of Olmesartan medoxomil and Azilsartan medoxomil in newly diagnosed patients with stage 1 Hypertension -A prospective observational open label study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaviya M |
| Designation |
M.D Post Graduate |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
PG Room,Department of pharmacology,Vinayaka Missions Kirupanada Variyar Medical college and Hospitals,Salem.
Vinayaka Missions kirupananda variyar Medical College And Hosptials,Sankari Mainroad,seeragapadi,salem,636308
Salem
TAMIL NADU
636308
India |
| Phone |
8973377443 |
| Fax |
|
| Email |
kaviyamuthusamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E.Manivannan |
| Designation |
Head of the Department of Pharmacology |
| Affiliation |
Vinayaka Missions Research foundation |
| Address |
Department OF pharmacology,Vinayaka Missions Kirupanada Variyar Medical college and Hospitals,Salem.
Salem
TAMIL NADU
636308
India |
| Phone |
8973377443 |
| Fax |
|
| Email |
manipoo73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaviya M |
| Designation |
Post graduate |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
Department of pharmacology ,Vinayaka Missions Kirupanada Variyar Medical college and Hospitals,Salem.
Salem
TAMIL NADU
636308
India |
| Phone |
8973377443 |
| Fax |
|
| Email |
kaviyamuthusamy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals,Salem,TamilNadu 636308 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kaviya M |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Department of Pharmacology,Vinayaka missions kirupananda variyar Medical College and Hospitals,seeragapadi,salem.
Salem
TAMIL NADU |
8973377443
kaviyamuthusamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Azilsartan medoxomil |
40 mg OD,oral for 3 months |
| Intervention |
Olmesartan Medoxomil |
20 mg OD,oral for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes aged more than 18 years with stage 1 hypertension (140-159 systolic BP/90-99 diastolic BP).
2. Patients with associated co-morbid conditions as diabetes, hypothyroidism without complications.
3. Patients who are willing to give consent for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with stage ll and lll hypertension.
2. Patients already on anti-hypertensive medications.
3. Patients with hypertensive urgencies and emergencies.
4. Along with additional comorbid diseases like coronary artery disease CCF, CKD, stroke and heart, kidney, liver complications.
5. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in systolic and diastolic BP |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record adverse effects of Olmesartan and Azilsartan such as dizziness, fatigue, headache, hyperglycemia.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2026 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized,open label,parralel group ,prospective study comparing the safety efficacyand tolerance of Olmesartan medoxomil 20 mg OD and Azilsartan medoxomil 40 mg OD for 3 months in 100 patients in a tertiary care centre in salem,Taminadu,India.Primary end point is reduction in both systolic and diastolic BP <140/90mmHg at the end of 1st ,2nd and 3rd month.Secondary end point is to record adverse effects of Olmesartan and Azilsartan such as dizziness, fatigue, headache, hyperglycemia. |