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

January 12, 2010 updated by: University of Pavia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • University of Pavia
      • Pavia, Italy
        • University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aliskiren/amlodipine
aliskiren, 300 mg/amlodipine 10 mg
Drug: aliskiren/amlodipine
aliskiren 300 mg /amlodipine 10 mg
Active Comparator: amlodipine
amlodipine 10 mg
Drug: aliskiren/amlodipine
aliskiren 300 mg /amlodipine 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Roberto Fogari, MD, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIPV001DIM2009
  • EudraCT 2009 (Registry Identifier: EudraCT 2009-016479-30)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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