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CTRI Number  CTRI/2024/02/062737 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing effect of telmisartan morning bedtime and divided doses in patients with high blood pressure  
Scientific Title of Study   Comparing Telmisartan Administration Regimens for Stage 1 Hypertension Treatment Morning Bedtime and Split Dose Approaches 
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 RIMPLE JEET KAUR 
Designation  Assistant Professor ,pharmacology  
Affiliation  All India institute of medical sciences jodhpur 
Address  Department of Pharmacology Second floor AIIMS medical college building AIIMS Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9784525975  
Fax    
Email  sidhurimple@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  DR RIMPLE JEET KAUR 
Designation  Assistant Professor ,pharmacology  
Affiliation  All India institute of medical sciences jodhpur 
Address  Department of Pharmacology Second floor AIIMS medical college building AIIMS Jodhpur Rajasthan


RAJASTHAN
342005
India 
Phone  9784525975  
Fax    
Email  sidhurimple@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR RIMPLE JEET KAUR 
Designation  Assistant Professor ,pharmacology  
Affiliation  All India institute of medical sciences jodhpur 
Address  Department of Pharmacology Second floor AIIMS medical college building AIIMS Jodhpur Rajasthan


RAJASTHAN
342005
India 
Phone  9784525975  
Fax    
Email  sidhurimple@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences Jodhpur Basni phase 2 Rajasthan 342005 
 
Primary Sponsor  
Name  Non funded study All India Institute of medical sciences Jodhpur  
Address  All India Institute of medical sciences Jodhpur Basni phase 2 Rajasthan 342005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rimple Jeet Kaur  All India Institute of Medical Sciences jodhpur   Department of general medicine Block A first floor OPD building AIIMS Hospital AIIMS jodhpur Basni phase 2 Rajasthan 342005
Jodhpur
RAJASTHAN 		 9784525975

sidhurimple@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of medical Sciences Jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Telmisartan 20 mg twice daily for 12 weeks   Group 3 Telmisartan 20 mg in the morning and Telmisartan 20 mg at bedtime for 12 weeks  
Intervention  Telmisartan 40 mg once daily for 12 weeks   Group 1 Telmisartan 40 mg once in the morning for 12 weeks  
Intervention  Telmisartan 40 mg once daily for 12 weeks  Group 2 Telmisartan 40 mg once at bedtime for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group 18 to 65 years
Newly diagnosed cases of Stage 1 hypertension
Patients willing to undergo Ambulatory Blood Pressure Monitoring ABPM and Automatic
Office Blood Pressure AOBP measurement  
 
ExclusionCriteria 
Details  Shift workers
Heavy drinkers intake and gt 80 gm per day
Heavy smokers 20 cigarettes per day
Patients with Type 1 diabetes mellitus
Patients with a history of cardiovascular disorders like unstable angina heart failure
arrhythmia, myocardial infarction, and coronary revascularization

Patients with a history of stroke
Patients with impaired kidney function
Pregnant women
Patients using non-steroidal anti-inflammatory drugs (NSAIDs) regularly 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
compare the efficacy of telmisartan in controlling the 24-hour mean systolic blood pressure and diastolic blood pressure after 12 weeks of administration as a single morning dose a single bedtime dose and divided morning and bedtime doses  compare the efficacy of telmisartan in controlling the 24-hour mean systolic blood pressure and diastolic blood pressure after 12 weeks of administration as a single morning dose a single bedtime dose and divided morning and bedtime doses 
 
Secondary Outcome  
Outcome  TimePoints 
compare the efficacy of telmisartan in controlling the mean diurnal SBP and DBP when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses after 12 weeks  Baseline and at 12 weeks 
compare the efficacy of telmisartan in controlling nocturnal mean SBP and mean DBP when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses after 12 weeks  Baseline and after 12 weeks 
compare the impact of telmisartan on fasting blood glucose creatinine
uric acid, cholesterol and triglyceride levels when administered as a single morning dose a single bedtime dose and divided morning and bedtime doses 		 Baseline and after 12 weeks 
compare the safety profile including adverse drug reactions of telmisartan when administered as a single morning dose a single bedtime dose and divided
Morning and bedtime doses 		 Baseline and after 12 weeks 
compare the differential effects of telmisartan on extreme nocturnal blood pressure dipping patterns specifically focusing on risers individuals exhibiting higher nocturnal BP than daytime BP and extreme dippers individuals exhibiting a marked nocturnal BP decline when administered as a single morning dose a single bedtime dose and divided morning and evening doses  Baseline and after 12 weeks 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 3 
Date of First Enrollment (India)   26/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   study will involve newly diagnosed hypertension  patients with systolic blood pressure between 140 and 159 mm Hg and diastolic blood pressure between 90 to 99 mm Hg who meet the inclusion and exclusion criteria and provide informed consent It is a 12 week duration study with patient follow up conducted at the end of 12 weeks Efficacy parameters will be assessed at baseline and at the end of the study Parameters measured will include systolic blood pressure  diastolic blood pressure and heart rate Measurements will be taken using a 48 hour ABPM device at baseline and at the end of the study ABPM will automatically record SBP DBP and HR every 20 minutes from 7 am to 11 pm and every 30 minutes at night for 48 hours Blood samples will be collected at the initiation and end of the study to assess fasting glucose urea creatinine cholesterol and triglyceride levels 
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