Skip to main content
OpenTrials
Completed

NCT Number: NCT07327749

Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

professor Kojuri cardiology clinic

Shiraz, Fars, 55318, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed stage 1 or stage 2 hypertension confirmed by 24-hour ambulatory blood pressure monitoring (ABPM).

Exclusion criteria

  • Severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
  • Contraindications to beta-blockers
  • Contraindication to calcium channel blocker
  • Contraindication to angiotensin receptor blockers
  • Significant comorbidities requiring specific therapy such as diabetes or chronic heart failure, or current use of medications that could interact with the study drugs were excluded
  • Pregnant or breastfeeding women
  • Individuals with suspected secondary hypertension, and those unable to adhere to follow-up procedures

Treatment and study plan

Bisoprolol

Drug

Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol

Other names: concor

valsartan and amlodipine

Drug

Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-amlodipine fix combination pill

Other names: valsartan-amlodipine fix combination pill

Primary outcomes

  1. mean blood pressure

    Time frame: 2 months

    mean blood pressure derived from 24 hours holter monitoring

  2. mean blood pressure nighttime

    Time frame: 2 months

    mean blood pressure at nighttime derived from 24 hours holter monitoring

Secondary outcomes

  1. drug adverse effect

    Time frame: 2 months

    any drug adverse effect reported by patient

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.