Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

NCT07327749 | Completed Phase 4

• 1 other identifier: IR.SUMS.MED.REC.1402.206
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

hypertension; bisoprolol; valsartan- amlodipine fix combination pill

Outcome Measures

Primary Outcomes (2)

• mean blood pressure

  mean blood pressure derived from 24 hours holter monitoring

  2 months

• mean blood pressure nighttime

  mean blood pressure at nighttime derived from 24 hours holter monitoring

  2 months

Secondary Outcomes (1)

• drug adverse effect

  2 months

Study Arms (2)

bisoprolol

ACTIVE COMPARATOR

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

Drug: Bisoprolol

Valsartan- Amlodipine fix dose combination

ACTIVE COMPARATOR

Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-Amlodipine

Drug: valsartan and amlodipine

Interventions

Bisoprolol DRUG

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

Also known as: concor

bisoprolol

valsartan and amlodipine DRUG

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

Also known as: valsartan-amlodipine fix combination pill

Valsartan- Amlodipine fix dose combination

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

professor Kojuri cardiology clinic

Shiraz, Fars, 55318, Iran

Location

MeSH Terms

Conditions

Hypertension

Interventions

Bisoprolol; Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Valsartan; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amlodipine; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 12, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)