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Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment
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Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment
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Journal Article
Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment
2024
Overview
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.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 692/4019
/ Adult
/ Aged
/ Amlodipine - administration & dosage
/ Amlodipine - adverse effects
/ Amlodipine - therapeutic use
/ Angiotensin receptor blocker
/ Antihypertensive Agents - administration & dosage
/ Antihypertensive Agents - adverse effects
/ Antihypertensive Agents - therapeutic use
/ Benzimidazoles - administration & dosage
/ Benzimidazoles - adverse effects
/ Benzimidazoles - therapeutic use
/ Biphenyl Compounds - administration & dosage
/ Biphenyl Compounds - adverse effects
/ Biphenyl Compounds - therapeutic use
/ Blood Pressure - drug effects
/ Essential Hypertension - drug therapy
/ Female
/ HTN
/ Humanities and Social Sciences
/ Humans
/ Male
/ Patients
/ Safety
/ Science
/ Tetrazoles - administration & dosage
/ Tetrazoles - adverse effects
