| CTRI Number |
CTRI/2026/02/104743 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate whether adding dapagliflozin to existing blood pressure treatment improves blood pressure control in patients with uncontrolled hypertension |
|
Scientific Title of Study
|
Effect of dapagliflozin 10 mg as add on therapy to existing antihypertensive medications on blood pressure and metabolic parameters in patients with uncontrolled hypertension attending a tertiary care hospital: An open label randomised interventional 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 Richa Sharma |
| Designation |
Postgraduate Student, Department of Pharmacology |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Pharmacology
Indira Gandhi Medical College
Shimla – 171001
Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459566235 |
| Fax |
|
| Email |
richasharma2194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purshottam Kaundal |
| Designation |
Head Of Department , Department of Pharmacology |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Pharmacology
Indira Gandhi Medical College
Shimla – 171001
Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9816120050 |
| Fax |
|
| Email |
pkkaundal66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Sharma |
| Designation |
Postgraduate Student, Department of Pharmacology |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Pharmacology
Indira Gandhi Medical College
Shimla – 171001
Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459566235 |
| Fax |
|
| Email |
richasharma2194@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College, Shimla |
| Address |
Indira Gandhi Medical College
Shimla – 171001
Himachal Pradesh
India |
| Type of Sponsor |
Government medical college |
|
|
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 Richa Sharma |
AIMSS Chamiana |
DEPARTMENT OF CARDIOLOGY, AIMSS CHAMIANA
Shimla
HIMACHAL PRADESH |
09459566235
richasharma2194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC Shimla |
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 |
| Intervention |
Dapagliflozin |
Dapagliflozin 10 milligram orally once daily as add on therapy to existing antihypertensive medications for a duration of 12 weeks. |
| Comparator Agent |
Standard antihypertensive therapy |
Continuation of existing antihypertensive medications with addition of another antihypertensive agent as clinically indicated, without addition of dapagliflozin, for a duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of hypertension with uncontrolled blood pressure of 140/90 mm of mercury or higher while receiving one or two antihypertensive drugs such as Telmisartan 40 mg once daily, Amlodipine 5 mg once daily, Enalapril 5 mg once daily, or their combination, with or without type 2 diabetes mellitus, will be considered for enrollment. Patients should be above 18 years of age and willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients with secondary hypertension or accelerated hypertension.
Patients with known hypersensitivity to sodium glucose co transporter 2 inhibitors.
Patients already receiving sodium glucose co transporter 2 inhibitors.
Pregnant or lactating women.
Patients with active urinary tract infection or genital mycotic infection |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic blood pressure and diastolic blood pressure after addition of dapagliflozin 10 mg to existing antihypertensive therapy. |
baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in fasting blood glucose, glycated haemoglobin, lipid profile, body weight, high sensitivity C reactive protein, blood urea nitrogen, serum creatinine, serum electrolytes, serum uric acid and urine routine and microscopy. |
Baseline and 12 weeks |
| Change in estimated glomerular filtration rate. |
Baseline and 12 weeks. |
| Change in echocardiographic parameters including left ventricular end diastolic dimension, left ventricular end systolic dimension, left ventricular ejection fraction and left atrial size. |
Baseline and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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
|
Phase 4 |
|
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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 aims to evaluate the effect of dapagliflozin 10 milligrams once daily as add on therapy to existing antihypertensive medications on blood pressure and metabolic parameters in patients with uncontrolled hypertension attending a tertiary care hospital. This is an open label randomized interventional study. Eligible patients aged 18 to 75 years with uncontrolled blood pressure despite receiving antihypertensive therapy comprising one or two agents such as Telmisartan 40 milligrams once daily, Amlodipine 5 milligrams once daily, Enalapril 5 milligrams once daily or their combination will be randomized into two groups. One group will receive dapagliflozin in addition to standard therapy and the other group will continue standard therapy alone. Participants will be followed for 12 weeks. The primary outcome is change in systolic blood pressure and diastolic blood pressure. Secondary outcomes include changes in metabolic parameters, renal function and echocardiographic parameters. |