Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: valsartan and amlodipine

Drug: Bisoprolol

Study type

Interventional

Funder types

Other

Identifiers

NCT07327749

IR.SUMS.MED.REC.1402.206

Details and patient eligibility

About

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

Full 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.

Enrollment

59 patients

Sex

All

Ages

30 to 59 years old

Volunteers

No Healthy Volunteers

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