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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518765

Enrollment

Registered

2007-08-21

Start date

2005-10-31

Completion date

Unknown

Last updated

2010-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers

Brief 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.

Interventions

DRUGAliskiren

DRUGAliskiren plus placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026