Hypertension
Conditions
Keywords
hypertension, bisoprolol, valsartan- amlodipine fix combination pill
Brief summary
Randomized comparison of bisoprolol 2.5 mg monotherapy with fix combination drug valsartan 80 mg- amlodipine 5 mg
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.
Interventions
DRUGBisoprolol
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-amlodipine fix combination pill
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean blood pressure | 2 months | mean blood pressure derived from 24 hours holter monitoring |
| mean blood pressure nighttime | 2 months | mean blood pressure at nighttime derived from 24 hours holter monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| drug adverse effect | 2 months | any drug adverse effect reported by patient |
Countries
Iran
Outcome results
None listed