Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients

University of Pavia88 enrolled

Overview

Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

aliskiren/amlodipineDRUG

aliskiren 300 mg /amlodipine 10 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diastolic blood pressure \> 95 mmHg and \< 110 mmHg * systolic blood pressure \> 140 mmHg and \< 180 mmHg * no amlodipine therapy for the previous 6 months Exclusion Criteria: * diastolic blood pressure \> 110 mmHg and or * systolic blood pressure \> 180 mmHg * secondary hypertension * heart failure * diabetes mellitus * liver or kidney diseases

Locations (2)

University of Pavia

Pavia, Italy

University of Pavia

Pavia, Italy

Outcomes

Primary Outcomes

Blood pressure, heart rate, ankle-foot volume

Time frame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Secondary Outcomes

Blood pressure and heart rate in sitting and standing position

Time frame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Data from ClinicalTrials.gov

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