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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048047
Recruitment Status : Unknown
Verified November 2009 by University of Pavia.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2010
Last Update Posted : January 13, 2010
Information provided by:
University of Pavia

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: aliskiren/amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01048047

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University of Pavia
Pavia, Italy, 27100
University of Pavia
Pavia, Italy
Sponsors and Collaborators
University of Pavia
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Principal Investigator: Roberto Fogari, MD University of Pavia
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Responsible Party: Roberto Fogari, University of Pavia Identifier: NCT01048047    
Other Study ID Numbers: UNIPV001DIM2009
EudraCT 2009 ( Registry Identifier: EudraCT 2009-016479-30 )
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: November 2009
Keywords provided by University of Pavia:
ankle-foot volume
mild and moderate hypertension
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents