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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hypertension; Ankle Edema

Treatments: Drug: Amlodipine; Drug: Placebo to Aliskiren/amlodipine; Drug: Placebo to Amlodipine; Drug: Aliskiren/amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080768

CSPA100A2201

2009-014359-63 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

31 participants in 2 patient groups

Aliskiren/amlodipine + Placebo to amlodipine

Experimental group

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.

Treatment:

Drug: Placebo to Amlodipine

Drug: Aliskiren/amlodipine

Amlodipine + Placebo to aliskiren/amlodipine

Active Comparator group

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.

Treatment:

Drug: Placebo to Aliskiren/amlodipine

Drug: Amlodipine