Official Title: “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"”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
• Drug: Aliskiren plus placebo
• Drug: Aliskiren
• Drug: Aliskiren plus placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Various sequences of different doses of Aliskiren
• Experimental: 2
  • Various sequences of different doses of Aliskiren plus placebo
• Experimental: 3
  • Various sequences of different doses of Aliskiren
• Experimental: 4
  • Various sequences of different doses of Aliskiren plus placebo

Primary Measures

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

Secondary Measures

• Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway
  • Time Frame: baseline, and at 5 hours, and 24 hours post dose
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Investigative site  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00518765

Study ID Number: CSPP100A2318

ClinicalTrials.gov Identifier: NCT00518765

Health Authority: United States: Food and Drug Administration