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

Last updated: June 28, 2024
Sponsor: Shiraz University of Medical Sciences
Overall Status: Completed

Phase

4

Condition

Stress

Williams Syndrome

Circulation Disorders

Treatment

valsartan 80 mg and amlodipine 5 mg as free combination

valsartan-amlodipine 80/5 mg FDC

Clinical Study ID

NCT06487949
IR.SUMS.MED.REC.1400.505
  • Ages 35-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/ordiastolic blood pressure > 80 mmHg), and required the initiation of antihypertensivemedications

Exclusion

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/ordiastolic 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

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: valsartan 80 mg and amlodipine 5 mg as free combination
Phase: 4
Study Start date:
December 01, 2022
Estimated Completion Date:
December 01, 2023

Study 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.

Connect with a study center

  • Shiraz University of Medical Sciences

    Shiraz, Fars 713481433
    Iran, Islamic Republic of

    Site Not Available

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