Trial reportJournal of clinical hypertension (Greenwich, Conn.)2026
Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial.
Trial report in Journal of clinical hypertension (Greenwich, Conn.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06052748 (A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
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Abstract
Low-dose single-pill combinations (SPCs) are gaining recognition as an efficient therapeutic strategy for mild hypertension. However, evidence from randomized controlled trials regarding the efficacy and safety of half-dose telmisartan/amlodipine SPCs remains limited. In this randomized, double-blind, active-controlled phase III trial, patients with essential hypertension [mean sitting systolic blood pressure (MSSBP) ≥ 140 and < 180 mmHg] were allocated to four treatment arms to receive either telmisartan/amlodipine 20/2.5 mg SPC (TEL/AML 20/2.5), or monotherapy with telmisartan 20 mg (TEL 20), amlodipine 2.5 mg (AML 2.5), or telmisartan 40 mg (TEL 40) once daily for 8 weeks. The primary endpoint was the change in MSSBP from baseline to week 8. A gatekeeping approach was used to test the superiority of TEL/AML 20/2.5 over TEL 20 and AML 2.5, followed by non-inferiority versus TEL 40. At week 8, TEL/AML 20/2.5 showed significantly greater MSSBP reductions compared with TEL 20 [least squares mean (LSM) differences: -5.79 mmHg; p = 0.0003] and AML 2.5 (-8.57 mmHg; p < 0.0001). Non-inferiority to TEL 40 was established, with an LSM difference of -3.88 mmHg (95% Confidence Interval: -6.67 to -1.09), which met the pre-specified 3 mmHg margin. The overall incidence of adverse events was 8.05%, with no statistically significant differences between groups. Overall, TEL/AML 20/2.5 SPC provided superior BP-lowering efficacy compared with TEL 20 and AML 2.5 monotherapies and was non-inferior to TEL 40. With a comparable safety profile across treatment groups, these findings suggest that TEL/AML 20/2.5 is a practical and effective option for hypertension management. Trial Registration: ClinicalTrials.gov, NCT06052748.
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