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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01080768
• Other study ID #: CSPA100A2201
• Secondary ID: 2009-014359-63
• Status: Terminated
• Phase: Phase 2
• First received: March 3, 2010
• Last updated: November 22, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Edema
• Hypertension

Intervention

Drug:
• Aliskiren/amlodipine
Aliskiren/amlodipine 150/5 mg/day
• Amlodipine
Amlodipine 5 mg/day.
• Placebo to Aliskiren/amlodipine
Placebo to Aliskiren/amlodipine 150/10 mg/day
• Placebo to Amlodipine
Placebo to Amlodipine 5 mg/day

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks	No