Trial reportDrug design, development and therapy2016
Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study.
Trial report in Drug design, development and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis.Clinical cardiology · 2023Pooled it
- 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.Drug design, development and therapy · 2026Trial
- Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects.Drug design, development and therapy · 2018Trial
- Spectrophotometric approach for deconvolving overlapped spectra of antihypertensive drug mixtures using UV detection: an eco-friendly method.BMC chemistry · 2025Article
- Green vibrational spectroscopic approach for simultaneous quantification of antihypertensive drugs in bulk and tablet formulations.Scientific reports · 2025Article
- Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study.Clinical hypertension · 2022Article
- Systematic Review with Network Meta-Analysis: Comparative Efficacy and Safety of Combination Therapy with Angiotensin II Receptor Blockers and Amlodipine in Asian Hypertensive Patients.International journal of hypertension · 2019Article
- S-Amlodipine: An Isomer with Difference-Time to Shift from Racemic Amlodipine.International journal of hypertension · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy. PATIENTS AND
methodsEligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.
resultsAfter the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (
conclusionCKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.
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