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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren; Drug: Aliskiren plus placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518765

CSPP100A2318

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 4 patient groups

1

Experimental group

Description:

Various sequences of different doses of Aliskiren

Treatment:

Drug: Aliskiren

Drug: Aliskiren

2

Experimental group

Description:

Various sequences of different doses of Aliskiren plus placebo

Treatment:

Drug: Aliskiren plus placebo

Drug: Aliskiren plus placebo

3

Experimental group

Description:

Various sequences of different doses of Aliskiren

Treatment:

Drug: Aliskiren

Drug: Aliskiren

4

Experimental group

Description:

Various sequences of different doses of Aliskiren plus placebo

Treatment:

Drug: Aliskiren plus placebo

Drug: Aliskiren plus placebo