| CTRI Number |
CTRI/2024/07/071545 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between effect of two drugs- amlodipine and telmisartan on people with high blood pressure on their blood sugar levels,lipid rofile and renal profile. |
|
Scientific Title of Study
|
A comparative study of amlodipine and telmisartan to assess the impact on glycemic status, lipid profile and renal parameters in drug naive hypertensive patients in eastern India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhajit Karmakar |
| Designation |
Post graduate trainee |
| Affiliation |
Midnapore medical college and hospital |
| Address |
Department of Pharmacology,Room-01,Medical division,Midnapore medical college and hospital, Vidyasagar Road, Midnapore, West Bengal
Medinipur
WEST BENGAL
721101
India |
| Phone |
7980356922 |
| Fax |
|
| Email |
subhajitrgkmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ram Narayan Maiti |
| Designation |
Head of department and professor,department of pharmacology |
| Affiliation |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology,Room-01,Medical division,Midnapore medical college and hospital, Vidyasagar Road, Midnapore, West Bengal
Medinipur
WEST BENGAL
721101
India |
| Phone |
7980356922 |
| Fax |
|
| Email |
ram.narayan.maiti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhajit Karmakar |
| Designation |
Post graduate trainee |
| Affiliation |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology,Room-01,Medical division,Midnapore medical college and hospital, Vidyasagar Road, Midnapore, West Bengal
Medinipur
WEST BENGAL
721101
India |
| Phone |
7980356922 |
| Fax |
|
| Email |
subhajitrgkmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Midnapore Medical College Hospital, Vidyasagar Road, Midnapore, Paschim Medinipur, Medinipur, West Bengal, 721101. |
|
|
Primary Sponsor
|
| Name |
Midnapore medical college and hospital |
| Address |
Midnapore medical college and hospital, Vidyasagar Road, Midnapore, West Bengal |
| 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 |
| Subhajit Karmakar |
Midnapore medical college and hospital |
Department of Pharmacology,Room-01,Medical division,Midnapore medical college and hospital, Vidyasagar Road, Midnapore, West Bengal
Medinipur
WEST BENGAL |
7980356922
subhajitrgkmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Midnapore Medical College and Hospital 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 |
Tablet amlodipine |
Tablet amlodipine at a dose of 5 mg is given orally once daily to 110 patients of primary hypertension selected by computer generated randomisation and physical and biochemcial parameters are then noted at baseline,third and sixth month respectively. |
| Intervention |
Tablet telmisartan |
Tablet telmisartan at a dose of 40 mg is given orally once daily to 110 patients selected by computer generated randomisation and physical and biochemical parameters are recorded at baseline,third and sixth month respectively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged between 18 and 65 years.
2.Patients newly diagnosed with hypertension(systolic blood pressure ≥140 mm hg and/or diastolic pressure ≥90 mmhg)
3.Patients with no history of diabetes mellitus,renal disease or hyperlipidemia.
4.Patients who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are already taking antihypertensive medications.
2.Patients with a history of allergic reactions to amlodipine or telmisartan.
3.Patients with a history of chronic diseases,such as diabetes mellitus,renal disease,or hyperlipidemia.
5.Pregnant or lactating women.
6.Patients who are unable or unwilling to provide informed consent.
7.Patients who are not taking any other medications that interfere glycemic status,lipid profile and renal parameters.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will give us knowledge and effectiveness and adverse effects of amlodipine and telmisartan and comparing the effects of these two drugs on glycemic status ,lipid profile and renal parameters.
|
Data will be collected at baseline,3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the adverse effect of both the drugs in these patients.
|
Data will be collected at baseline, third & sixth month.
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
09/08/2024 |
| 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 Applicable |
| 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
|
The study result could lead to changes in current guidelines for managing hypertension and inform drug selection for hypertensive patients in the future.In conclusion,the proposed study is highly relevant and could lead to significant improvement in the management of hypertension in eastern India reducing the risk of developing associated complications. |