Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: valsartan-amlodipine 80/5 mg FDC

Drug: valsartan 80 mg and amlodipine 5 mg as free combination

Study type

Interventional

Funder types

Other

Identifiers

NCT06487949

IR.SUMS.MED.REC.1400.505

Details and patient eligibility

About

Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.

Full description

Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications.

This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.

Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.

Enrollment

114 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications

Exclusion criteria

Patients previously been on antihypertensive drugs
Patients had secondary high blood pressure
Patients had severe high blood pressure (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg)
Patients had ischemic heart disease in the past
Patients were unable to receive any part of the treatment
Patients who refuse to take part in study