Text Size

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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01080768
First received: March 3, 2010
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01080768     History of Changes
Other Study ID Numbers: CSPA100A2201, 2009-014359-63
Study First Received: March 3, 2010
Results First Received: November 22, 2011
Last Updated: November 22, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
Pedal edema
hypertension
aliskiren
amlodipine

Additional relevant MeSH terms:
Edema
Hypertension
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013