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

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

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.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase III

MeSH terms

  • Adult
  • Aged
  • Amlodipine* / administration & dosage
  • Amlodipine* / adverse effects
  • Amlodipine* / therapeutic use
  • 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
  • Double-Blind Method
  • Drug Therapy, Combination*
  • Essential Hypertension / drug therapy
  • Female
  • Humans
  • Hypertension* / drug therapy
  • Male
  • Middle Aged
  • Tetrazoles* / administration & dosage
  • Tetrazoles* / adverse effects
  • Tetrazoles* / therapeutic use
  • Treatment Outcome

Substances

  • Amlodipine
  • candesartan cilexetil
  • Benzimidazoles
  • Antihypertensive Agents
  • Biphenyl Compounds
  • Tetrazoles