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

Comparison of morning vs. evening administration of Amlodipine/Valsartan in hypertensive patients at Loghman hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240131060872N1
Enrollment
100
Registered
2024-04-10
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II hypertension according to ACC/AHA2017 definition. Essential (primary) hypertension

Interventions

Intervention 1: Intervention group1 :Recipient of Amlodipine/Valsartan medicine in the evening with a single dose of 160.5 or 80.5 (according to the conditions of each patient) from Dr. Abidi's compan

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Hadian

Shahid Beheshti University of Medical Sciences

marjan7437@gmail.com+98 21 5541 9005

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026