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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
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
January 12, 2010
Last Updated
January 12, 2010
Sponsor
University of Pavia
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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

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

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