Effectiveness and safety of a New Standardised TrEatment Protocol based on initial/early therapy with single-pill combinations of blood pressure-lowering drugs for improving blood pressure control (NewSTeP): Rationale, design of a randomized clinical trial and baseline characteristics of the trial participants

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=300). Intervention: New Standardised Treatment Protocol (NewSTeP) based on initial/early single-pill combinations (SPCs) vs. Usual care (antihypertensive treatment at the discretion of the treating physician). Primary outcome: Difference in change in home seated mean systolic blood pressure (SBP) from randomization to month 6 (effectiveness) and percentage of participants discontinuing trial drug due to adverse events (safety).

Q: What does this research mean for the field?

The NewSTeP trial successfully randomized 300 Indian adults with hypertension to evaluate an early single-pill combination standardised treatment protocol versus usual care, with full trial outcomes pending. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Rupasvi Dhurjati; Rashmi Pant; Amit Kumar; Anshika Mittal; Krishnaiah Chappidi; Gautam Satheesh; Parul Puri; Sasi Kumar Tiruttani; Shwetha Rajaram; Aneesh Basheer; Prabhdeep Kaur; Andrew Moran; Andrés Rosende; Poongothai Subramani; Sandeep Mahajan; Nupur Lalvani; Sandeep Bansal; Dorairaj Prabhakaran; Jayagopal Pathiyil Balagopalan; Stephen Jan; Mark D. Huffman; Vivekanand Jha; Abdul Salam

doi:10.64898/2026.09.10.26362712

Key result

NewSTeP trial tests early single-pill combination strategy versus usual care in Indian adults with hypertension.

n=300

Why the study?

Suboptimal BP control is driven in part by reluctance to initiate combination therapy and delayed treatment intensification. While early use of single-pill combinations within standardised treatment protocols may improve outcomes, evidence from India was limited.

Does a new standardised treatment protocol incorporating initial or early use of single-pill combinations (telmisartan, amlodipine, chlorthalidone) improve home-measured systolic blood pressure control and maintain safety compared with usual care in adults with hypertension in India?

Key Points

To evaluate the effectiveness and safety of a standardized treatment protocol incorporating initial or early single-pill combination therapy compared with usual care in adults with hypertension in India.
Pragmatic, multicenter, randomized, parallel-group, open-label trial conducted across nine tertiary healthcare centers in India.
Randomized 300 adults with hypertension (untreated or taking one blood pressure drug and requiring treatment intensification) 1:1 to either a standardized protocol with early single-pill combinations or usual care for 6 months.
Primary outcomes are change in home-measured mean systolic blood pressure at 6 months and trial drug discontinuation due to adverse events.
Between October 2025 and March 2026, 300 participants were randomized from 360 screened individuals (150 allocated to the new standardized protocol and 150 to usual care).
Follow-up is scheduled through September 2026, with primary clinical effectiveness, safety, implementation, and cost-effectiveness outcomes anticipated in October 2026.

Study Design

Type

RCT (n=300)

Blinding

Open-label

Randomization

1:1 central block randomization (variable block sizes of 2 and 4), stratified by trial site and baseline BP-lowering treatment status (0 or 1 drug)

Multicenter

Yes

Structured PICO

Does a new standardised treatment protocol incorporating initial or early use of single-pill combinations (telmisartan, amlodipine, chlorthalidone) improve home-measured systolic blood pressure control and maintain safety compared with usual care in adults with hypertension in India?

P

Population

300 adults with hypertension in India (mean age 51.4 years, 43.3% female), either untreated or receiving one antihypertensive medication and free of established cardiovascular disease or eGFR <60 mL/min/1.73 m², followed for 6 months.

I

Intervention

New Standardised Treatment Protocol (New STP) incorporating initial or early oral single-pill combinations (SPCs) once daily over 6 months: Step 1 consists of dual SPC (telmisartan 40 mg + amlodipine 5 mg); Step 2 consists of triple SPC (telmisartan 40 mg + amlodipine 5 mg + chlorthalidone 12.5 mg); Step 3 escalates to one tablet of the triple SPC plus one tablet of the dual SPC once daily; Step 4 is referral to a hypertension specialist.

C

Comparator

Usual care, consisting of antihypertensive treatment at the discretion of the treating physician over 6 months (both arms received free trial drugs, lifestyle counselling, and protocol-required home BP monitoring devices).

O

Outcome

Primary effectiveness outcome: difference in change in home-measured seated mean systolic blood pressure (SBP) from randomization to month 6. Primary safety outcome: percentage of participants who discontinue trial drugs due to adverse events from randomization to month 6.surrogate

Limitations

Open-label design where blinding of participants and site staff was not feasible
Relatively small number of study sites (9 sites), which may limit representativeness and generalizability to all healthcare contexts
Six-month follow-up period may not capture longer-term adherence or clinical cardiovascular outcomes
Exclusion of patients with established cardiovascular disease, advanced kidney disease, and severe hypertension (BP ≥180/110 mmHg) limits generalizability to higher-risk populations
Open-label design where blinding of participants and site staff is not feasible

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Implication

This trial design and baseline characteristics report establishes a pragmatic randomized evaluation of an early single-pill combination standardised treatment protocol for hypertension in India, where 300 patients with high baseline comorbidity burden (49% diabetes) have been enrolled.

Abstract

Background Hypertension is the leading modifiable risk factor for cardiovascular disease (CVD). Despite availability of blood pressure (BP)-lowering therapies, BP control rates remain suboptimal. Reluctance to initiate treatment with combination therapy and delayed treatment intensification contribute to poor control. Early use of single-pill combinations (SPCs) within standardised treatment protocols (STPs) may improve outcomes, but evidence from India is limited. Objective To evaluate the effectiveness and safety of a new STP incorporating initial or early use of SPCs compared with usual care among adults with hypertension. Methods The New Standardised TrEatment Protocol (NewSTeP) trial is a pragmatic, multicentre, randomized, parallel-group, open-label trial conducted in tertiary healthcare centres in India. Adults with hypertension who are untreated or receiving one BP-lowering drug and require treatment initiation or intensification (n = 300) will be randomized 1:1 to either a new STP incorporating early SPC therapy or usual care. Participants will be followed for 6 months. The primary effectiveness outcome is change in home-measured mean systolic BP from randomization to month 6. The primary safety outcome is discontinuation of trial drug due to adverse events. Secondary outcomes include proportion of participants achieving BP control, change in diastolic BP, incidence of adverse events of special interest, treatment adherence, treatment modification, and time to BP control. A process evaluation will assess reach, implementation, acceptability, and sustainability, while an economic evaluation will assess cost-effectiveness. Results Between October 2025 and March 2026, 300 participants were randomized across nine sites (150 to New STP; 150 usual care) from 360 screened individuals. Final follow-up is expected in September 2026, with results anticipated in October 2026. Conclusions The NewSTeP trial will provide evidence on the effectiveness, safety, implementation, and cost-effectiveness of an SPC-based STP for hypertension management in India and inform future hypertension control strategies and policies. Trial Registration The trial is registered with the Clinical Trials Registry–India (CTRI/2025/07/091649).

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Cite This Study

Dhurjati et al. (2026) conducted an RCT in Hypertension (n=300). New Standardised Treatment Protocol (NewSTeP) based on initial/early single-pill combinations (SPCs) vs. Usual care (antihypertensive treatment at the discretion of the treating physician) was evaluated on Difference in change in home seated mean systolic blood pressure (SBP) from randomization to month 6 (effectiveness) and percentage of participants discontinuing trial drug due to adverse events (safety).

synapsesocial.com/papers/6aed1332e932c72f2a1a3270 https://doi.org/10.64898/2026.09.10.26362712

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Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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