A pragmatic, multicentre randomized trial enrolling 300 Indian adults with untreated or undertreated hypertension has been launched to compare a standardized treatment protocol (STP) featuring early single-pill combinations (SPCs) of antihypertensives against usual care. Participants are randomized 1:1 across nine tertiary sites, with the primary endpoint being change in home-measured systolic blood pressure at six months. Secondary endpoints include proportion achieving BP control, treatment adherence, time to control, and adverse event rates. Results are anticipated in October 2026.
This preprint — not yet peer-reviewed — describes trial design and baseline characteristics only; no efficacy data are yet available. That context is critical: what's being assessed here is trial infrastructure and enrollment feasibility, not outcomes. The clinical rationale, however, is well-grounded. Decades of global evidence, including the landmark ACCOMPLISH and HOPE-3 trials, confirm that fixed-dose combination therapy improves adherence and BP control versus sequential monotherapy. India carries a disproportionate hypertension burden with notoriously low control rates, making locally generated evidence especially policy-relevant. The trial's pragmatic design — open-label, real-world tertiary settings — enhances generalizability but introduces performance and detection bias risks. The modest sample size of 300 limits power to detect safety signals or subgroup effects. The inclusion of process and economic evaluations is a meaningful strength, directly informing scalable implementation. If results confirm effectiveness, this could accelerate SPC adoption in India's national hypertension guidelines — an incremental but practically significant advance.