NCT06487949

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

Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	valsartan-amlodipine 80/5 mg FDC	fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill
DRUG	valsartan 80 mg and amlodipine 5 mg as free combination	Free combination of valsartan 80 mg and amlodipine 5 mg given separately

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: Iran