Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
aliskiren/amlodipine
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring aliskiren, amlodipine, hypertension, ankle-foot volume, mild and moderate hypertension
Eligibility Criteria
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
Sites / Locations
- University of Pavia
- University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aliskiren/amlodipine
amlodipine
Arm Description
aliskiren, 300 mg/amlodipine 10 mg
amlodipine 10 mg
Outcomes
Primary Outcome Measures
Blood pressure, heart rate, ankle-foot volume
Secondary Outcome Measures
Blood pressure and heart rate in sitting and standing position
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01048047
Brief Title
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pavia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
aliskiren, amlodipine, hypertension, ankle-foot volume, mild and moderate hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aliskiren/amlodipine
Arm Type
Experimental
Arm Description
aliskiren, 300 mg/amlodipine 10 mg
Arm Title
amlodipine
Arm Type
Active Comparator
Arm Description
amlodipine 10 mg
Intervention Type
Drug
Intervention Name(s)
aliskiren/amlodipine
Intervention Description
aliskiren 300 mg /amlodipine 10 mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Fogari, MD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
University of Pavia
City
Pavia
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
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