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

This study has been terminated.
(Publication of data from a similar study made the current study redundant.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080768
First Posted: March 4, 2010
Last Update Posted: December 26, 2011
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Condition Intervention Phase
Hypertension Ankle Edema Drug: Aliskiren/amlodipine Drug: Amlodipine Drug: Placebo to Aliskiren/amlodipine Drug: Placebo to Amlodipine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01080768


Locations
Netherlands
Novartis Investigative Site
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01080768     History of Changes
Other Study ID Numbers: CSPA100A2201
2009-014359-63 ( EudraCT Number )
First Submitted: March 3, 2010
First Posted: March 4, 2010
Results First Submitted: November 22, 2011
Results First Posted: December 26, 2011
Last Update Posted: December 26, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pedal edema
hypertension
aliskiren
amlodipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents