Overview

This trial is active, not recruiting.

Condition hypertension
Treatment aliskiren/amlodipine
Phase phase 4
Sponsor University of Pavia
Start date November 2009
End date December 2009
Trial size 88 participants
Trial identifier NCT01048047, EudraCT 2009, UNIPV001DIM2009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aliskiren, 300 mg/amlodipine 10 mg
aliskiren/amlodipine
aliskiren 300 mg /amlodipine 10 mg
(Active Comparator)
amlodipine 10 mg
aliskiren/amlodipine
aliskiren 300 mg /amlodipine 10 mg

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Principal investigator Roberto Fogari, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by University of Pavia.