Ignite Creation Date:
2024-07-17 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487949
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Valsartan and Amlodipine in Blood Pressure Management Fixed-Dose vs Free Drug Therapy
Sponsor:
Shiraz University of Medical Sciences
Organization:
Shiraz University of Medical Sciences
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension HTN was randomized to receive either Valsartan 80 mgAmlodipine 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 ACCAHA Guidelines systolic blood pressure 130 mmHg andor 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 processPatients 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
This study used the permutation block randomization method block size 4 for the randomization processPatients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None