Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

December 26, 2025 updated by: Javad Kojuri, Shiraz University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Fars
      • Shiraz, Fars, Iran, 55318
        • professor Kojuri cardiology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bisoprolol
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol
Drug: Bisoprolol
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol
Other Names:
  • concor
Active Comparator: Valsartan- Amlodipine fix dose combination
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-Amlodipine
Drug: valsartan and amlodipine
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-amlodipine fix combination pill
Other Names:
  • valsartan-amlodipine fix combination pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean blood pressure
Time Frame: 2 months
mean blood pressure derived from 24 hours holter monitoring
2 months
mean blood pressure nighttime
Time Frame: 2 months
mean blood pressure at nighttime derived from 24 hours holter monitoring
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug adverse effect
Time Frame: 2 months
any drug adverse effect reported by patient
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SUMS.MED.REC.1402.206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available with rational request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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