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

Phase 4

• Conditions: Hypertension
• Interventions: Drug: aliskiren/amlodipine

• Registration Number: NCT01048047
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Primary Completion: 2009-12
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Last Update Submitted: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Posted: 2010-01-13
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aliskiren/amlodipine	aliskiren/amlodipine	aliskiren, 300 mg/amlodipine 10 mg
amlodipine	aliskiren/amlodipine	amlodipine 10 mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, Italy