NCT07327749

Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

Bisoprolol Monotherapy Versus Valsartan-Amlodipine for Hypertension Management in Adults Younger Than 60: Results of a Randomized Triple-Blind Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

Randomized comparison of bisoprolol 2.5 mg monotherapy with fix combination drug valsartan 80 mg- amlodipine 5 mg

Detailed description

In this randomized, triple-blind, two-arm clinical trial, 59 adults aged 18-60 years with newly diagnosed stage 1-2 hypertension were assigned to bisoprolol 2.5 mg once daily (n=30) or a valsartan 80 mg + amlodipine 5 mg single-pill combination (n=29) for two months. Blood pressure was assessed using 24-hour ambulatory monitoring at baseline and after treatment. Statistical analysis included paired t-tests, ANOVA, and nonparametric methods, with significance set at p\<0.05.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Bisoprolol	Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol
DRUG	valsartan and amlodipine	Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-amlodipine fix combination pill

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-01
• Completion: 2025-12-12
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Iran