CTRI

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CTRI Number

CTRI/2025/07/091649 [Registered on: 24/07/2025] Trial Registered Prospectively

Last Modified On:

31/03/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Improving Blood Pressure Control in People with Hypertension Through a Treatment Protocol of Early Combination Therapy.

Scientific Title of Study

Effectiveness and implementation of a treatment protocol based on initial or early therapy with fixed dose combinations of blood pressure lowering drugs for improving blood pressure control - NewSTeP

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
TGI-IA-HTN-AS-1 Version 2.0 dated 27/05/2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Professor Vivekananda Jha
Designation	Principal Investigator
Affiliation	The George Institute for Global Health, India
Address	The George Institute For Global Health India Plot No 58 And 59 Ground Floor Saranya Building Nagarjuna Circle Punjagutta Hyderabad Telangana 500082 Hyderabad TELANGANA 500082 India
Phone	914049959780
Fax
Email	vjha@georgeinstitute.org.in

Details of Contact Person
Scientific Query

Name	Dr Mohammad Abdul Salam
Designation	Program Head
Affiliation	The George Institute for Global Health, India
Address	The George Institute For Global Health India Plot No 58 And 59 Ground Floor Saranya Building Nagarjuna Circle Punjagutta Hyderabad Telangana 500082 Hyderabad TELANGANA 500082 India
Phone	914049959779
Fax
Email	asalam@georgeinstitute.org.in

Details of Contact Person
Public Query

Name	Dr Mohammad Abdul Salam
Designation	Program Head
Affiliation	The George Institute for Global Health, India
Address	The George Institute For Global Health India Plot No 58 And 59 Ground Floor Saranya Building Nagarjuna Circle Punjagutta Hyderabad Telangana 500082 Hyderabad TELANGANA 500082 India
Phone	914049959779
Fax
Email	asalam@georgeinstitute.org.in

Source of Monetary or Material Support

The George Institute For Global Health India

Primary Sponsor

Name	The George Institute For Global Health, India
Address	The George Institute For Global Health, India. Plot No 58 and 59, Ground Floor, Saranya Building, Nagarjuna Circle, Punjagutta, Hyderabad, Telangana - 500082
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 11
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Navneet Singh Gill	Akash Healthcare Pvt Ltd	Hospital Plot, Road No. 201, Dwarka Sector-3, Dwarka, New Delhi, Delhi, 110075 South West DELHI	91 98102 03522 gillenclave@rediffmail.com
Dr Sindhu Joshi	Bhagwan Mahavir Medical Research Centre	#10-1-1, Bhagwan Mahavir Marg, AC Guards, Near Masab Tank Flyover, Masab Tank, Hyderabad, Telangana 5000028. Hyderabad TELANGANA	9391099991 drsindhujoshi.bmmrc@gmail.com
Dr Sanjay D Cruz	Govt.Medical college & Hospital	Sector 32, Chandigarh -160030, India Chandigarh CHANDIGARH	9646121556 sanjaydcruz@gmch.gov.in
Dr Balaji Tamilselvan	Hindu Mission Hospital	103, GST Road, West Tambaram, Chennai – 600 045. Tamil Nadu. India. Chennai TAMIL NADU	9962133002 baladoc29@gmail.com
Dr Jaya Gopal	Lakshmi Hospital	Chittur Road, Palakkad - 678 013, Kerala- India Palakkad KERALA	9847023777 jaigopallakshmi@gmail.com
Dr Mohan V	Madras Diabetes Research Foundation	No 4, Conron Sith Road, Gopalapuram, Chennai -600086. Tamil Nadu. India Chennai TAMIL NADU	9840134505 drmohans@diabetes.ind.in
Dr Rakesh Sahay	Osmania Hospital	Room No: 306, 2nd Floor, Department of Endocrinology, ,Osmania Medical College, Afzalgunj, Hyderabad-500012, Telangana, India Hyderabad TELANGANA	9849597507 sahayrk@gmail.com
Dr Deba Prasad Dhibar	Post Graduate Institute of Medical Education & Research, Chandigarh (PGIMER)	Sector-12, Chandigarh,Pin- 160 012, India Chandigarh CHANDIGARH	95308 81462 drdeba_prasad@yahoo.co.in
Dr Aneesh Basheer	SRMMCH&RC	Mahatma Gandhi Rd, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu - 603211 Kancheepuram TAMIL NADU	9677154338 basheeraneesh@gmail.com
Dr Venkatesra Rao	St Theresa Hospital	Sanathnagar, Hyderabad-500018, Telangana, India Hyderabad TELANGANA	9440040662 drvenkateshwarraoavula@gmail.com
Dr Sandeep Bansal	VMMC & Safdarjang hospital	Ministry of Health & F.W., Govt. of India New Delhi - 110 029 New Delhi DELHI	0 drsbansal2000@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 9
Name of Committee	Approval Status
Aakash Healthcare Institutional Ethics Committee	Approved
Ethics Committee St Theresas Hospital	Approved
IEC of Madras Diabetes Research Foundation	Approved
Institutional Ethics committee for Biomedical research Bhagwan Mahavir Medical Research Centre	Approved
Institutional Ethics Committee Government Medical College Chandigarh	Approved
Institutional Ethics committee Hindu Mission Hospital	Approved
Institutional Ethics Committee, Lakshmi Hospital	Approved
Institutional Ethics Committee, Osmania Medical College	Approved
The SRM Institutional Ethics committee	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
Intervention	New hypertension standardized treatment protocol (STP)	Dual Fixed-Dose Combination (Telmisartan 40 mg + Amlodipine 5 mg) OR Triple Fixed-Dose Combination (Telmisartan 40 mg + Amlodipine 5 mg + Chlorthalidone 12.5 mg) OR Dual Fixed-Dose Combination (Telmisartan 40 mg + Amlodipine 5 mg) + Triple Fixed-Dose Combination (Telmisartan 40 mg + Amlodipine 5 mg + Chlorthalidone 12.5 mg
Comparator Agent	usual care	Blood pressure lowering drugs available in Indian market, as per Investigators discretion.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	79.00 Year(s)
Gender	Both
Details	Inclusion criteria At screening visit 1.Adults (age 18-79 years) 2.Have diagnosis of hypertension: a. Documented previous diagnosis of hypertension and/or currently using BP-lowering drugs for hypertension OR b. Clinic attended automated seated mean SBP (average of last 2 measurements) more than or equal to 140 mmHg and/or DBP more than or equal to 90 mmHg on screening visit day AND At least one documented prior clinic SBP more than or equal to 140 mmHg and/or DBP more than or equal to 90 mmHg 3. Untreated for hypertension or on one BP-lowering drug for more than or equal to 2 weeks 4. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based on BP at this and/or previous visits 5.Willingness to use home BP measurement device and measure BP at home for 6 months 6.Provided signed informed consent to participate in the trial At randomization visit 1.Untreated for hypertension or on one BP-lowering drug for more than or equal to 2 weeks 2. Clinic attended automated seated mean (average of last 2 measurements) SBP 140-179 mmHg and/or DBP 90-109 mmHg 3. Willingness to use home BP measurement device and measure BP at home for 6 months 4. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based on BP at this and/or previous visits

ExclusionCriteria

Details

Exclusion criteria
At screening visit
1. Receiving 2 or more BP-lowering drugs (FDC containing two BP-lowering drugs should be considered as 2 BP-lowering drugs)
2. Receiving any BP-lowering drugs for primary indications other than hypertension (e.g., migraine, benign prostate hyperplasia, heart failure)
3. Known current/history of secondary hypertension, cardiovascular disease, including coronary heart disease, angina, myocardial infarction, acute coronary syndrome, congestive heart failure, atrial fibrillation, stroke or transient ischemic attack
4. Known current/history of end-stage renal disease or anuria or current estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2
5. Women who are pregnant, or had a positive pregnancy test, or unwilling to take a pregnancy test before randomization and/or during the trial, breastfeeding, or of childbearing potential and not using effective contraception during the trial period
6. Contraindication, including hypersensitivity (e.g., anaphylaxis or angioedema) to any trial medications or procedures
7. Participation in any investigational medication and/or device trial within the 30 days prior to randomization
8. Current concomitant illness or physical impairment or mental condition or abnormal laboratory value, which in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants’ safety or well-being
At randomization visit
1. SBP more than or equal to 180 or DBP more than or equal to 110 mmHg
2. Fulfilling any of the exclusion criteria mentioned for the screening visit, when assessed again

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1- Primary efficacy outcome: Difference in change in home seated mean SBP 2- Primary safety outcome: Percentage of participants who discontinued trial medication due to AEs or SAEs	1- Primary efficacy outcome: Randomization to Month 6 2- Primary safety outcome: Randomization to Month 6

Secondary Outcome

Outcome	TimePoints
Percentage of participants achieving clinic seated mean SBP less than 140 mmHg and DBP less than 90 mmHg	Month 1, Month 3 and Month 6
Percentage of participants achieving clinic seated mean SBP less than 135 mmHg and DBP less than 85 mmHg	Month 1, Month 3 and Month 6
Percentage of participants achieving clinic seated mean SBP less than 130 mmHg and DBP less than 80 mmHg	Month 1, Month 3 and Month 6
Percentage of participants achieving home seated mean SBP less than 130 mmHg and DBP less than 80 mmHg	Month 1, Month 3 and Month 6
Difference in change in home seated mean DBP	Randomization to Month 6
Difference in change in clinic seated mean SBP and DBP	Randomization to Month 1, Month 3, and Month 6
Difference in change in home seated mean SBP and DBP	Randomization to month 1 and Month 3
Percentage of participants with incidence of adverse events of special interest (AESI)	Randomization to Month 6
Adherence to BP-lowering medication	Randomization to Month 6
Percentage of participants with modification of BP-lowering therapy (intensification, lessening, change, withdrawal)	Randomization to Month 6
Time taken to achieve BP control	Randomization to Month 6
Other outcome Number of healthcare facility (including study site) visits related to hypertension	Randomization to Month 6
Other outcome Percentage of participants treated with full adherence to the new hypertension STP	Randomization to Month 6
Other outcome Percentage of referrals to hypertension specialists	Randomization to Month 6

Target Sample Size

Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300"

Phase of Trial

N/A

Date of First Enrollment (India)

08/08/2025

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

Evaluate, among adults with hypertension, the effectiveness and safety of the new hypertension STP compared to usual care for improving blood pressure control.