Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension: The OPTION TREAT Trial
Primary resultResult — go to the resultBetween-group difference −4.4 mm Hg 90% CI −6.3 to −2.5Authors' conclusion
In patients with uncontrolled hypertension, a novel triple single-pill containing candesartan cilexetil, amlodipine, and chlorthalidone improved BP control at 12 weeks and had a reasonable safety profile.
Study context
- Population
- Uncontrolled hypertension (office SBP 140–180 mm Hg and DBP 90–110 mm Hg) despite dual therapy
- Participants
- 703 participants
- Comparison
- Triple single-pill vs active control
- Primary endpoint
- Mean change in office SBP from baseline
- Follow-up
- Week 12
Methodological detailsdouble-blind, double-dummy, non-inferiority, 19 sites in Brazil
- Double-blind
- Double-dummy
- Non-inferiority
- 19 sites in Brazil
Primary result
As reported in the abstract
12 weeks
Between-group difference
−4.4 mm Hg
90% CI −6.3 to −2.5
P < 0.001
By group
Experimental
−22.6
least square mean change · mm Hg
Control
−18.2
least square mean change · mm Hg
Experimentalvs Control
between-group difference −4.4 mm Hg (90% CI −6.3 to −2.5); P < 0.001
Non-inferiority margin 3 as printed, not drawn
Secondary outcomes
mm Hg
| Outcome | Experimental | Control | P value |
|---|---|---|---|
| Mean change in DBP | −13.8 | −12.0 | P = 0.008 |
Safety
- Serious adverse events were rare
Original publication
Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension: The OPTION TREAT Trial. JACC Adv. Published 29 August 2025. doi:10.
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