Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

Shiraz University of Medical Sciences59 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

BisoprololDRUG

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

valsartan and amlodipineDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

professor Kojuri cardiology clinic

Shiraz, Fars, Iran

Outcomes

Primary Outcomes

mean blood pressure

mean blood pressure derived from 24 hours holter monitoring

Time frame: 2 months

mean blood pressure nighttime

mean blood pressure at nighttime derived from 24 hours holter monitoring

Time frame: 2 months

Secondary Outcomes

drug adverse effect

any drug adverse effect reported by patient

Time frame: 2 months

Data from ClinicalTrials.gov

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