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

University of Pavia

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: aliskiren/amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01048047

UNIPV001DIM2009

EudraCT 2009 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

aliskiren/amlodipine

Experimental group

Description:

aliskiren, 300 mg/amlodipine 10 mg

Treatment:

Drug: aliskiren/amlodipine

amlodipine

Active Comparator group

Description:

amlodipine 10 mg

Treatment:

Drug: aliskiren/amlodipine