Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

Study Overview
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Brief Summary
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This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.

Official Title
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A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet Renin Inhibition and the Kidney

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Drug: Aliskiren plus placebo
* Drug: Aliskiren
* Drug: Aliskiren plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects age 18 to 75 years of age included Strictly adhere to provided diet. Exclusion Criteria: Symptomatic low blood pressure Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function Over-the-counter medication 2 weeks before study start Clinically significant heart abnormalities. Previous history of allergy to the study drug or drugs similar to the study drug. Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study. Other protocol-defined inclusion/exclusion criteria apply

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Various sequences of different doses of Aliskiren | Drug: Aliskiren<br> <br> * Other names: SPP100;|
| Experimental: 2<br>Various sequences of different doses of Aliskiren plus placebo | Drug: Aliskiren plus placebo<br> <br> |
| Experimental: 3<br>Various sequences of different doses of Aliskiren | Drug: Aliskiren<br> <br> * Other names: SPP100;|
| Experimental: 4<br>Various sequences of different doses of Aliskiren plus placebo | Drug: Aliskiren plus placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet |  | baseline and hourly intervals. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway |  | baseline, and at 5 hours, and 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers