CTRI/2025/07/091649
Completed
Not Applicable
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
The George Institute For Global Health, India11 sites in 1 country300 target enrollmentStarted: August 8, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The George Institute For Global Health, India
- Enrollment
- 300
- Locations
- 11
- Primary Endpoint
- 1- Primary efficacy outcome:
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 79.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •Untreated for hypertension or on one BP-lowering drug for more than or equal to 2 weeks
- •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
- •Clinic attended automated seated mean (average of last 2 measurements) SBP 140-179 mmHg and/or DBP 90-109 mmHg
- •Willingness to use home BP measurement device and measure BP at home for 6 months
- •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.
Exclusion Criteria
- •Exclusion criteria At screening visit
- •Receiving 2 or more BP-lowering drugs (FDC containing two BP-lowering drugs should be considered as 2 BP-lowering drugs)
- •Receiving any BP-lowering drugs for primary indications other than hypertension (e.g., migraine, benign prostate hyperplasia, heart failure)
- •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
- •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
- •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
- •Contraindication, including hypersensitivity (e.g., anaphylaxis or angioedema) to any trial medications or procedures
- •Participation in any investigational medication and/or device trial within the 30 days prior to randomization
- •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
- •SBP more than or equal to 180 or DBP more than or equal to 110 mmHg
Outcomes
Primary Outcomes
1- Primary efficacy outcome:
Time Frame: 1- Primary efficacy outcome: Randomization to Month 6 | 2- Primary safety outcome: Randomization to Month 6
Difference in change in home seated mean SBP
Time Frame: 1- Primary efficacy outcome: Randomization to Month 6 | 2- Primary safety outcome: Randomization to Month 6
2- Primary safety outcome:
Time Frame: 1- Primary efficacy outcome: Randomization to Month 6 | 2- Primary safety outcome: Randomization to Month 6
Percentage of participants who discontinued trial medication due to AEs or SAEs
Time Frame: 1- Primary efficacy outcome: Randomization to Month 6 | 2- Primary safety outcome: Randomization to Month 6
Secondary Outcomes
- 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)
- Other outcome(Percentage of participants treated with full adherence to the new hypertension STP)
- Other outcome(Percentage of referrals to hypertension specialists)
Investigators
Professor Vivekananda Jha
The George Institute for Global Health, India
Study Sites (11)
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