Effect of Time-of-Day Administration of Amilodipine/Valsartan on Hypertention Control

Phase 3

Recruiting

• Conditions: Stage II hypertension according to ACC/AHA2017 definition.; Essential (primary) hypertension

• Registration Number: IRCT20240131060872N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age range between 35-75
Absence of underlying disease such as no renal diseases, no diabetes mellitus, and no cardiovascular diseases
No previous history of hypertension treatment
Consent to enter the study

Exclusion Criteria

Having renal diseases
Having diabetes Mellitus
Having cardiovascular diseases including ischemic, non-ischemic, and heart failure

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of people who have systolic blood pressure above 140 and/or diastolic blood pressure above 90. Timepoint: Blood pressure measurement at the beginning of the study (before the start of the intervention), 14 days and 56 days after the start of receiving the combination drug Amilodipine/Valsartan. Method of measurement: Holter device for measuring blood pressure.

Secondary Outcome Measures

Name	Time	Method
Ankle edema. Timepoint: After 14 days from the start of the study. Method of measurement: Questionnaire and physical examination.;Hyperkalemia. Timepoint: After 14 days from the start of the study. Method of measurement: Questionnaire and serum k test.;Acute kidney injury. Timepoint: After 14 days from the start of the study. Method of measurement: Questionnaire, physical examination, serum Cr, urea, and urine analysis (U/A).;Orthostatic vertigo. Timepoint: After 14 days from the start of the study. Method of measurement: Questionnaire and physical examination.