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

Hypertension Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01048047
• Other study ID #: UNIPV001DIM2009
• Secondary ID: EudraCT 2009
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2009
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• aliskiren/amlodipine
aliskiren 300 mg /amlodipine 10 mg

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia
Italy	University of Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure, heart rate, ankle-foot volume		At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks	Yes
Secondary	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	Yes