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

Phase 4

Completed

Interventions: Drug: valsartan-amlodipine 80/5 mg FDC
Drug: valsartan 80 mg and amlodipine 5 mg as free combination

Brief 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.

Recruitment & Eligibility

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/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications

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/or diastolic 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

Arm && Interventions

Group	Intervention	Description
valsartan- Amlodipine fix dose combination pill	valsartan-amlodipine 80/5 mg FDC	Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill
Valsartan- Amlodipine free dose combination	valsartan 80 mg and amlodipine 5 mg as free combination	Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately

Primary Outcome Measures

Name	Time	Method
Mean 24 hours systolic blood pressure	8 weeks	The average systolic blood pressure over 24 hours, during the day and at night
Mean 24 hours diastolic blood pressure	8 weeks	The average diastolic blood pressure over 24 hours, during the day and at night
Mean 24 hours mean blood pressure	8 weeks	The average mean blood pressure over 24 hours, during the day and at night

Secondary Outcome Measures

Name	Time	Method
Dipping	8 weeks	Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days

Locations (1): Shiraz University of Medical Sciences
🇮🇷
Shiraz, Fars, Iran, Islamic Republic of

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