Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

November 22, 2011 updated by: Novartis Pharmaceuticals

A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

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

  • Netherlands
      • Beek en Donk, Netherlands
        • Novartis Investigative Site
      • Bosch, Netherlands
        • Novartis Investigative Site
      • Den Haag, Netherlands
        • Novartis Investigative Site
      • Hoogwoud, Netherlands
        • Novartis Investigative Site
      • Lichtenvoorde, Netherlands
        • Novartis Investigative Site
      • Lieshout, Netherlands
        • Novartis Investigative Site
      • Poortvliet, Netherlands
        • Novartis Investigative Site
      • Utrecht, Netherlands
        • Novartis Investigative Site
      • Wildervank, Netherlands
        • Novartis Investigative Site

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (male or female) with hypertension aged between 18-75 yrs.
  • Patients not treated with amlodipine or no amlodipine in previous 1 year.
  • Post-menopausal females

Exclusion Criteria:

  • Patients unable to switch from prior hypertensive medication.
  • Severe hypertension.
  • Pregnant or nursing females.
  • Patients with Type 1 or Type 2 diabetes mellitus
  • History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay [ELISA] and Western blot) test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria are applied

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aliskiren/amlodipine + Placebo to amlodipine

During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Drug: Aliskiren/amlodipine
Aliskiren/amlodipine 150/5 mg/day
Other Names:
  • SPA100
Drug: Placebo to Amlodipine
Placebo to Amlodipine 5 mg/day
ACTIVE_COMPARATOR: Amlodipine + Placebo to aliskiren/amlodipine

During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Drug: Amlodipine
Amlodipine 5 mg/day.
Drug: Placebo to Aliskiren/amlodipine
Placebo to Aliskiren/amlodipine 150/10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
Time Frame: Baseline, 4 weeks
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
Baseline, 4 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

February 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (ESTIMATE)

March 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 26, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPA100A2201
  • 2009-014359-63 (EUDRACT_NUMBER)

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.

Clinical Trials on Hypertension

Clinical Trials on Aliskiren/amlodipine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe