Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-12

Brief Summary

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

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Detailed Description

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bisoprolol

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

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

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

Valsartan- Amlodipine fix dose combination

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

Group Type ACTIVE_COMPARATOR

valsartan and amlodipine

Intervention Type DRUG

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

Interventions

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Bisoprolol

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

Intervention Type DRUG

valsartan and amlodipine

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

Intervention Type DRUG

Other Intervention Names

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concor valsartan-amlodipine fix combination pill

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No