What question did this study set out to answer?

This trial aimed to evaluate the efficacy and safety of a low-dose combination of telmisartan and S-amlodipine versus higher-dose telmisartan monotherapy in patients with hypertension.

May 22, 2026Drug Design Development and TherapyOpen Access

Efficacy and Safety of Telmisartan 20 mg/S-Amlodipine 2.5 mg versus Telmisartan 40 mg in Patients with Hypertension, Inadequately Controlled on Telmisartan 20 mg Monotherapy: 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 telmisartan 20 mg monotherapy (n=108). Intervention: Telmisartan/S-amlodipine vs. Telmisartan 40 mg once daily. Primary outcome: Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8 (Mean difference -9.56 mmHg, 95% CI -14.50 to -4.61, p=<0.001).

Q: What does this research mean for the field?

A low-dose combination of telmisartan 20 mg and S-amlodipine 2.5 mg provides superior blood pressure reduction and favorable tolerability compared to telmisartan 40 mg monotherapy in patients with hypertension inadequately controlled on telmisartan 20 mg. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

View Full Paper

Ask AI

Bookmark

Why the study?

To evaluate the efficacy and safety of low-dose combination telmisartan 20 mg/S-amlodipine 2.5 mg versus telmisartan 40 mg monotherapy in patients with essential hypertension inadequately controlled on telmisartan 20 mg.

Does telmisartan 20 mg/S-amlodipine 2.5 mg combination therapy improve blood pressure reduction compared to telmisartan 40 mg monotherapy in patients with essential hypertension inadequately controlled on telmisartan 20 mg?

Population

108 patients with essential hypertension inadequately controlled on telmisartan 20 mg

Comparison

Telmisartan 20 mg/S-amlodipine 2.5 mg vs telmisartan 40 mg

Design

Randomized, double-blind, multicenter, phase 3 trial

Follow-up

8 weeks

Key result

Telmisartan 20 mg/S-amlodipine 2.5 mg reduced mean sitting systolic blood pressure by an additional 9.56 mmHg compared to telmisartan 40 mg in patients with inadequately controlled hypertension.

Authors

JYJong‐Chan Youn EKEui-Soon Kim TPTae Ho Park

Discussion

Member takes

Overview

May support low-dose combination over monotherapy for systolic BP reduction; leaves open confirmation in larger outcome trials.

Key Points

This trial aimed to evaluate the efficacy and safety of a low-dose combination of telmisartan and S-amlodipine versus higher-dose telmisartan monotherapy in patients with hypertension.
Randomized, double-blind design over 8 weeks
108 patients with uncontrolled hypertension received either T20/SA2.5 or T40
Primary endpoint was change in mean sitting systolic blood pressure from baseline to week 8.
T20/SA2.5 group achieved greater reduction in MSSBP (−16.97 mmHg vs. −7.42 mmHg; P<0.001)
Higher BP control rate with T20/SA2.5 (53.7% vs. 29.6%; P=0.010)
Lower incidence of treatment-emergent adverse events with T20/SA2.5 (9.26% vs. 20.37%, P=0.104).

Study Design

Type

RCT (n=108)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Population

108 patients with essential hypertension inadequately controlled on telmisartan 20 mg monotherapy (defined as mean sitting systolic blood pressure ≥ 140 mmHg, or ≥ 130 mmHg for patients with cardiovascular or chronic kidney disease) after a 4-week run-in period.

Intervention

Telmisartan 20 mg / S-amlodipine 2.5 mg combination therapy for 8 weeks

Comparator

Telmisartan 40 mg monotherapy for 8 weeks

Outcome

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

Main Result

Effect estimate: Mean difference -9.56 mmHg (95% CI -14.50 to -4.61)

Absolute Event Rate: -16.97% vs -7.42%

p-value: p=<0.001

Low-dose combination therapy with telmisartan 20 mg and S-amlodipine 2.5 mg provides superior blood pressure reduction and favorable tolerability compared to doubling the dose to telmisartan 40 mg in patients with uncontrolled hypertension.

Limitations

Relatively small sample size
Short follow-up duration limiting the ability to assess long-term outcomes
Study population restricted to Korean patients, which may limit generalizability to other populations

Cite This Study

Youn et al. (2026) conducted an RCT in Essential hypertension inadequately controlled on telmisartan 20 mg monotherapy (n=108). Telmisartan/S-amlodipine vs. Telmisartan 40 mg once daily was evaluated on Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8 (Mean difference -9.56 mmHg, 95% CI -14.50 to -4.61, p=<0.001). Telmisartan 20 mg/S-amlodipine 2.5 mg reduced mean sitting systolic blood pressure by an additional 9.56 mmHg compared to telmisartan 40 mg in patients with inadequately controlled hypertension.

synapsesocial.com/papers/6a0ff362d674f7c03778c0f1 https://doi.org/10.2147/dddt.s587488

View Full Paper

Ask AI

Bookmark

May 22, 2026Drug Design Development and TherapyOpen Access

Efficacy and Safety of Telmisartan 20 mg/S-Amlodipine 2.5 mg versus Telmisartan 40 mg in Patients with Hypertension, Inadequately Controlled on Telmisartan 20 mg Monotherapy: A Randomized, Double-Blind, Multicenter, Phase 3 Trial

View Full Paper

Ask AI

Bookmark

Why the study?

Population

108 patients with essential hypertension inadequately controlled on telmisartan 20 mg

Comparison

Telmisartan 20 mg/S-amlodipine 2.5 mg vs telmisartan 40 mg

Design

Randomized, double-blind, multicenter, phase 3 trial

Follow-up

8 weeks

Key result

Telmisartan 20 mg/S-amlodipine 2.5 mg reduced mean sitting systolic blood pressure by an additional 9.56 mmHg compared to telmisartan 40 mg in patients with inadequately controlled hypertension.

Authors

JYJong‐Chan Youn EKEui-Soon Kim TPTae Ho Park

Discussion

Member takes

Overview

May support low-dose combination over monotherapy for systolic BP reduction; leaves open confirmation in larger outcome trials.

Key Points

This trial aimed to evaluate the efficacy and safety of a low-dose combination of telmisartan and S-amlodipine versus higher-dose telmisartan monotherapy in patients with hypertension.
Randomized, double-blind design over 8 weeks
108 patients with uncontrolled hypertension received either T20/SA2.5 or T40
Primary endpoint was change in mean sitting systolic blood pressure from baseline to week 8.
T20/SA2.5 group achieved greater reduction in MSSBP (−16.97 mmHg vs. −7.42 mmHg; P<0.001)
Higher BP control rate with T20/SA2.5 (53.7% vs. 29.6%; P=0.010)
Lower incidence of treatment-emergent adverse events with T20/SA2.5 (9.26% vs. 20.37%, P=0.104).

Study Design

Type

RCT (n=108)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Population

Intervention

Telmisartan 20 mg / S-amlodipine 2.5 mg combination therapy for 8 weeks

Comparator

Telmisartan 40 mg monotherapy for 8 weeks

Outcome

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

Main Result

Effect estimate: Mean difference -9.56 mmHg (95% CI -14.50 to -4.61)

Absolute Event Rate: -16.97% vs -7.42%

p-value: p=<0.001

Limitations

Relatively small sample size
Short follow-up duration limiting the ability to assess long-term outcomes
Study population restricted to Korean patients, which may limit generalizability to other populations

Cite This Study

synapsesocial.com/papers/6a0ff362d674f7c03778c0f1 https://doi.org/10.2147/dddt.s587488

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

View Full Paper

Ask AI

Bookmark