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Clinical Trial
. 2024 Oct 3;14(1):22940.
doi: 10.1038/s41598-024-74003-5.

Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment

Moon-Seung Soh  1 , Kyung-Heon Won  2 , Jae-Joong Kim  3 , Sung Yun Lee  4 , Min Su Hyon  5 , Ho-Joong Youn  6 , Seung-Woon Rha  7 , Doo-Il Kim  8 , Youngkeun Ahn  9 , Byung Jin Kim  10 , Dong-Ju Choi  11 , Jong-Seon Park  12 , Dae-Kyung Kim  13 , Woo-Jung Park  14 , Hong-Seok Lim  15 , Seung-Jea Tahk  16
Affiliations
Clinical Trial

Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment

Moon-Seung Soh et al. Sci Rep. .

Abstract

Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone.

Keywords: Amlodipine; Angiotensin receptor blocker; Antihypertensive; Blood pressure; Candesartan Cilexetil; HTN.

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Conflict of interest statement

This study was funded by HK inno.N Corp. (formerly CJ Healthcare), Seoul, Korea. The sponsor was responsible for data collation and statistical analysis, which was supported by Chung Hyun Choi, an employee of HK inno.N Corp. Soohong Kim, an employee of HK inno.N Corp., assisted with the preparation of the manuscript, but did not meet the criteria for authorship. The authors declare no other competing interests.

Figures

Fig. 1
Fig. 1
Study design. AML, amlodipine; CC, candesartan cilexetil.
Fig. 2
Fig. 2
Disposition of the participants. AML, amlodipine; CC, candesartan cilexetil.
Fig. 3
Fig. 3
Change in DBP from baseline. ** p -value less than 0.001. DBP, diastolic blood pressure; AML, amlodipine; CC, candesartan cilexetil.
Fig. 4
Fig. 4
Change in SBP from baseline. **p-value less than 0.001. SBP, systolic blood pressure; AML, amlodipine; CC, candesartan cilexetil.
See this image and copyright information in PMC

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