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

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

Official Title
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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

Conditions
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Hypertension, Ankle Edema

Intervention / Treatment
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* Drug: Aliskiren/amlodipine
* Drug: Amlodipine
* Drug: Placebo to Aliskiren/amlodipine
* Drug: Placebo to Amlodipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren/amlodipine + Placebo to amlodipine<br>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. | Drug: Aliskiren/amlodipine<br>* Aliskiren/amlodipine 150/5 mg/day<br>* Other names: SPA100;Drug: Placebo to Amlodipine<br>* Placebo to Amlodipine 5 mg/day<br>|
| Active Comparator: Amlodipine + Placebo to aliskiren/amlodipine<br>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. | Drug: Amlodipine<br>* Amlodipine 5 mg/day.<br>Drug: Placebo to Aliskiren/amlodipine<br>* Placebo to Aliskiren/amlodipine 150/10 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pedal edema, hypertension, aliskiren, amlodipine