| CTRI Number |
CTRI/2024/02/062389 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
EMR Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study to assess effectiveness and Safety of Amlodipine and Telmisartan. |
|
Scientific Title of Study
|
Effectiveness and Safety of Amlodipine and Telmisartan
in Treatment Naïve Hypertension: An EMR-based
Retrospective, Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-040-HYPE/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Katare |
| Designation |
Overall Trial coordinator |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Mujtaba Hussain Naqvi |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
7032969523 |
| Fax |
|
| Email |
mujtabanaqvi@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Katare |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India, Hyderabad, TELANGANA, 500016, India Hyderabad
TELANGANA 500016 India
Hyderabad
TELANGANA
500016
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited
7-1-27, Ameerpet, Hyderabad 500016,Telangana, India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India |
| 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 Jay Shah |
Healthplix Technologies |
Clinical insights Department, AWFIS, Vajram Esteva, 2nd floor, No-57 4, Devarabisanahalli, Outer
Ring Road, Bellandur, Bengaluru, Karnataka 560103
Bangalore
KARNATAKA |
9898209755
jayshah08@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune independent 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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Treatment-naïve patients with essential or primary hypertension.
Patients who were prescribed amlodipine or telmisartan monotherapy as first line therapy. |
|
| ExclusionCriteria |
| Details |
Patients with secondary hypertension.
Patients prescribed with any other antihypertensive drug
Patients prescribed with any combination of antihypertensive drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SBP and DBP from baseline to 12 weeks. |
An interim visit of 2 weeks and a final visit of 12 weeks will be considered for analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in heart rate and assessment of pedal edema |
Baseline to 2, and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
15/02/2024 |
| 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="0"
Months="6"
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
|
While Amlodipine and Telmisartan are widely used antihypertensive drugs, there is a lack of head to head comparative studies in newly diagnosed hypertensive patients. There is a need for comparative studies to determine which drug is more effective and safer for naïve patient population. |