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June 3, 2026Journal of Hypertension

Efficacy and Safety of Low-Dose Telmisartan/S-Amlodipine Combination: Integrated Results From Two Korean Phase Iii Trials

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Why the study?

The study was conducted to evaluate the efficacy and safety of a novel low-dose combination of telmisartan 20 mg and S-amlodipine 1.25 mg in patients with mild-to-moderate hypertension.

Does a low-dose combination of telmisartan and S-amlodipine improve blood pressure reduction compared to monotherapies in patients with mild-to-moderate hypertension?

Population

576 patients with mild-to-moderate uncontrolled hypertension

Comparison

Telmisartan/S-amlodipine 20/1.25 mg vs amlodipine 5 mg, telmisartan 20 mg, or S-amlodipine 1.25 mg

Design

Integrated analysis of two randomized, double-blind, multicenter phase III trials

Follow-up

8 weeks

Key result

Low-dose telmisartan/S-amlodipine (20/1.25 mg) achieved superior reduction in mean sitting systolic blood pressure compared to amlodipine 5 mg (-17.57 vs -13.90 mmHg; p<0.05).

Authors

JNJ. O. NaJSJinho ShinICIn-Ho Chae

Discussion

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Overview

Supports low-dose telmisartan/S-amlodipine initiation in mild-moderate hypertension; extends RCT evidence for fixed-dose ARB/CCB combinations.

Key Points

  • The aim was to assess the efficacy and safety of a low-dose telmisartan/S-amlodipine combination in treating mild-to-moderate hypertension.
  • Two phase III randomized, double-blind, multicenter trials were conducted in Korea.
  • Patients with uncontrolled hypertension were randomized to receive either the combination therapy, amlodipine, or monotherapy for 8 weeks.
  • Primary endpoint was the change in mean sitting systolic blood pressure from baseline to week 8.
  • Combination therapy reduced mean sitting systolic blood pressure by -17.57 mmHg (p<0.0001).
  • Statistically significant superiority in blood pressure reduction was seen versus amlodipine and monotherapies (p<0.05).
  • Adverse event rates were similar between the combination and monotherapy groups, indicating good tolerability.

Study Design

Type

RCT (n=576)

Blinding

double-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Does a low-dose combination of telmisartan and S-amlodipine improve blood pressure reduction compared to monotherapies in patients with mild-to-moderate hypertension?

P
Population
576 patients with mild-to-moderate uncontrolled hypertension (msSBP 140-179 mmHg, msDBP <110 mmHg) treated for 8 weeks.
I
Intervention
Telmisartan 20 mg and S-amlodipine 1.25 mg combination once daily for 8 weeks
C
Comparator
Amlodipine 5 mg, telmisartan 20 mg, or S-amlodipine 1.25 mg once daily for 8 weeks
O
Outcome
Change in mean sitting systolic blood pressure (msSBP) from baseline to week 8surrogate

Main Result

Absolute Event Rate: -17.57% vs -13.9%

p-value: p=<0.05

A low-dose combination of telmisartan 20 mg and S-amlodipine 1.25 mg provides superior blood pressure reduction compared to standard monotherapies in patients with mild-to-moderate hypertension.

Cite This Study

Na et al. (2026) conducted an RCT in mild-to-moderate hypertension (n=576). telmisartan/S-amlodipine vs. amlodipine 5 mg, telmisartan 20 mg, or S-amlodipine 1.25 mg was evaluated on change in mean sitting systolic blood pressure (msSBP) from baseline to week 8 (p=<0.05). Low-dose telmisartan/S-amlodipine (20/1.25 mg) achieved superior reduction in mean sitting systolic blood pressure compared to amlodipine 5 mg (-17.57 vs -13.90 mmHg; p<0.05).

synapsesocial.com/papers/6a1fc44edee9eb8c0dce5d4fhttps://doi.org/10.1097/01.hjh.0001195556.90442.39
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Also Consider

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

  1. 1Efficacy 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 Trial2026
  2. 2Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study2022 · 3 citations
  3. 3O92 EFFICACY AND SAFETY OF LOW-DOSE ANTIHYPERTENSIVE COMBINATION DRUGS INCLUDING AMLODIPINE, TELMISARTAN, AND CHLORTHALIDONE: A MULTICENTER, RANDOMIZED, DOUBLE-BLINDED, PARALLEL, PHASE II CLINICAL TRIAL2024
  4. 4Low‐Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial2026
  5. 5Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT2026 · 1 citations