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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Captopril

Criteria

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