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

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.

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