What does this research mean for the field?

A single-pill triple combination of valsartan, amlodipine, and chlorthalidone significantly improves blood pressure reduction without increasing serious adverse events compared to valsartan/amlodipine dual therapy in patients with inadequately controlled essential hypertension. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To evaluate the efficacy and safety of a single-pill triple combination of valsartan, amlodipine, and chlorthalidone versus dual therapy in patients with essential hypertension inadequately controlled on valsartan and amlodipine.

September 14, 2026Journal of Clinical HypertensionOpen Access

Efficacy and Safety of a Single‐Pill Triple Combination of Valsartan, Amlodipine, and Chlorthalidone in Patients With Essential Hypertension Inadequately Controlled on Dual Therapy With Valsartan and Amlodipine: A Randomized, Double‐Blind, Multicenter, Phase 3 Trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Essential hypertension inadequately controlled on dual therapy (n=193). Intervention: Valsartan, amlodipine, and chlorthalidone vs. Valsartan/amlodipine 80/5 mg escalated to 160/5 mg. Primary outcome: Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8 (MD -10.99 mmHg, 95% CI -14.56 to -7.41, p=< 0.0001).

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Why the study?

Does a single-pill triple combination of valsartan, amlodipine, and chlorthalidone reduce blood pressure more effectively than dual therapy in patients with inadequately controlled essential hypertension?

Population

193 patients in South Korea with essential hypertension inadequately controlled after 4 weeks of dual…

Comparison

Single-pill triple combination therapy with… vs Dual therapy with valsartan and amlodipine for a…

Design

RCT, 1:1, double-blind, double-dummy design

Follow-up

8 weeks

Key result

Valsartan/amlodipine/chlorthalidone triple therapy significantly reduced mean sitting systolic blood pressure compared to dual therapy (difference -10.99 mmHg; 95% CI, -14.56 to -7.41; p<0.0001).

Authors

ICIn‐Jeong Cho SHSoon Jun Hong MKMin Gyu Kong

Discussion

Member takes

Overview

Supports triple over dual therapy for uncontrolled hypertension; reinforces that many patients require three or more agents.

Key Points

To evaluate the efficacy and safety of a single-pill triple combination of valsartan, amlodipine, and chlorthalidone versus dual therapy in patients with essential hypertension inadequately controlled on valsartan and amlodipine.
Multicenter, randomized, double-blind phase 3 trial conducted in South Korea (NCT06416865) enrolling 193 patients with uncontrolled blood pressure following 4 weeks of valsartan/amlodipine 80/5 mg.
Participants were randomized 1:1 to either valsartan/amlodipine/chlorthalidone (80/5/12.5 mg) or valsartan/amlodipine (80/5 mg) using a double-dummy design, with doses escalated after 2 weeks to 160/5/25 mg and 160/5 mg, respectively, for 6 weeks (8 weeks total follow-up; 178 completed).
The least squares mean ± SE change in mean sitting systolic blood pressure at week 8 was -19.70 ± 1.31 mmHg in the triple therapy group versus -8.71 ± 1.26 mmHg in the dual therapy control group, demonstrating a significant between-group difference of -10.99 ± 1.81 mmHg (95% CI, -14.56 to -7.41; p < 0.0001).
Serious adverse events occurred in 0% of patients in the triple therapy group compared with 1.98% in the dual therapy control group (p = 0.4985).

Study Design

Type

RCT (n=193)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Population

193 patients with essential hypertension inadequately controlled on valsartan/amlodipine dual therapy, evaluated over an 8-week period.

Intervention

Single-pill triple combination therapy with valsartan, amlodipine, and chlorthalidone (initial dose 80/5/12.5 mg, escalated after 2 weeks to 160/5/25 mg) for a total treatment duration of 6 weeks.

Comparator

Dual therapy with valsartan and amlodipine (initial dose 80/5 mg, escalated after 2 weeks to 160/5 mg) for a total treatment duration of 6 weeks, using a double-dummy design.

Outcome

Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8.surrogate

Main Result

Mean Difference: -10.99 (95% CI -14.56–-7.41)

Absolute Event Rate: -19.7% vs -8.71%

p-value: p=< 0.0001

A single-pill triple combination of valsartan, amlodipine, and chlorthalidone provides superior blood pressure reduction compared to dual therapy in patients with inadequately controlled essential hypertension.

Cite This Study

Cho et al. (2026) conducted an RCT in Essential hypertension inadequately controlled on dual therapy (n=193). Valsartan, amlodipine, and chlorthalidone vs. Valsartan/amlodipine 80/5 mg escalated to 160/5 mg was evaluated on Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8 (MD -10.99 mmHg, 95% CI -14.56 to -7.41, p=< 0.0001). Valsartan/amlodipine/chlorthalidone triple therapy significantly reduced mean sitting systolic blood pressure compared to dual therapy (difference -10.99 mmHg; 95% CI, -14.56 to -7.41; p<0.0001).

synapsesocial.com/papers/6aa7afef79e9260bc85aac85 https://doi.org/10.1111/jch.70362

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September 14, 2026Journal of Clinical HypertensionOpen Access

Efficacy and Safety of a Single‐Pill Triple Combination of Valsartan, Amlodipine, and Chlorthalidone in Patients With Essential Hypertension Inadequately Controlled on Dual Therapy With Valsartan and Amlodipine: A Randomized, Double‐Blind, Multicenter, Phase 3 Trial

View Full Paper

Ask AI

Bookmark

Why the study?

Population

193 patients in South Korea with essential hypertension inadequately controlled after 4 weeks of dual…

Comparison

Single-pill triple combination therapy with… vs Dual therapy with valsartan and amlodipine for a…

Design

RCT, 1:1, double-blind, double-dummy design

Follow-up

8 weeks

Key result

Valsartan/amlodipine/chlorthalidone triple therapy significantly reduced mean sitting systolic blood pressure compared to dual therapy (difference -10.99 mmHg; 95% CI, -14.56 to -7.41; p<0.0001).

Authors

ICIn‐Jeong Cho SHSoon Jun Hong MKMin Gyu Kong

Discussion

Member takes

Overview

Supports triple over dual therapy for uncontrolled hypertension; reinforces that many patients require three or more agents.

Key Points

To evaluate the efficacy and safety of a single-pill triple combination of valsartan, amlodipine, and chlorthalidone versus dual therapy in patients with essential hypertension inadequately controlled on valsartan and amlodipine.
Multicenter, randomized, double-blind phase 3 trial conducted in South Korea (NCT06416865) enrolling 193 patients with uncontrolled blood pressure following 4 weeks of valsartan/amlodipine 80/5 mg.
Participants were randomized 1:1 to either valsartan/amlodipine/chlorthalidone (80/5/12.5 mg) or valsartan/amlodipine (80/5 mg) using a double-dummy design, with doses escalated after 2 weeks to 160/5/25 mg and 160/5 mg, respectively, for 6 weeks (8 weeks total follow-up; 178 completed).
The least squares mean ± SE change in mean sitting systolic blood pressure at week 8 was -19.70 ± 1.31 mmHg in the triple therapy group versus -8.71 ± 1.26 mmHg in the dual therapy control group, demonstrating a significant between-group difference of -10.99 ± 1.81 mmHg (95% CI, -14.56 to -7.41; p < 0.0001).
Serious adverse events occurred in 0% of patients in the triple therapy group compared with 1.98% in the dual therapy control group (p = 0.4985).

Study Design

Type

RCT (n=193)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Population

193 patients with essential hypertension inadequately controlled on valsartan/amlodipine dual therapy, evaluated over an 8-week period.

Intervention

Single-pill triple combination therapy with valsartan, amlodipine, and chlorthalidone (initial dose 80/5/12.5 mg, escalated after 2 weeks to 160/5/25 mg) for a total treatment duration of 6 weeks.

Comparator

Dual therapy with valsartan and amlodipine (initial dose 80/5 mg, escalated after 2 weeks to 160/5 mg) for a total treatment duration of 6 weeks, using a double-dummy design.

Outcome

Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8.surrogate

Main Result

Mean Difference: -10.99 (95% CI -14.56–-7.41)

Absolute Event Rate: -19.7% vs -8.71%

p-value: p=< 0.0001

Cite This Study

synapsesocial.com/papers/6aa7afef79e9260bc85aac85 https://doi.org/10.1111/jch.70362

View Full Paper

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