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

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine

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