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

Primary Purpose

Hypertension, Ankle Edema

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Aliskiren/amlodipine
Amlodipine
Placebo to Aliskiren/amlodipine
Placebo to Amlodipine
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Pedal edema, hypertension, aliskiren, amlodipine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aliskiren/amlodipine + Placebo to amlodipine

Amlodipine + Placebo to aliskiren/amlodipine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2010
Last Updated
November 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01080768
Brief Title
Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Publication of data from a similar study made the current study redundant.
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Ankle Edema
Keywords
Pedal edema, hypertension, aliskiren, amlodipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren/amlodipine + Placebo to amlodipine
Arm Type
Experimental
Arm Description
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.
Arm Title
Amlodipine + Placebo to aliskiren/amlodipine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aliskiren/amlodipine
Other Intervention Name(s)
SPA100
Intervention Description
Aliskiren/amlodipine 150/5 mg/day
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine 5 mg/day.
Intervention Type
Drug
Intervention Name(s)
Placebo to Aliskiren/amlodipine
Intervention Description
Placebo to Aliskiren/amlodipine 150/10 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo to Amlodipine
Intervention Description
Placebo to Amlodipine 5 mg/day
Primary Outcome Measure Information:
Title
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
Description
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.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Beek en Donk
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bosch
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Den Haag
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hoogwoud
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Lichtenvoorde
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Lieshout
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Poortvliet
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Utrecht
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Wildervank
Country
Netherlands

12. IPD Sharing Statement

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

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