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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01048047

Enrollment

Registered

2010-01-13

Start date

2009-11-30

Completion date

2010-03-31

Last updated

2010-01-13

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

Conditions

Hypertension

Keywords

aliskiren, amlodipine, hypertension, ankle-foot volume, mild and moderate hypertension

Brief summary

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.

Interventions

DRUGaliskiren/amlodipine

aliskiren 300 mg /amlodipine 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Blood pressure, heart rate, ankle-foot volume	At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Secondary

Measure	Time frame
Blood pressure and heart rate in sitting and standing position	At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026