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

NCT ID: NCT00518765

Last Updated: 2010-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Various sequences of different doses of Aliskiren

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

2

Various sequences of different doses of Aliskiren plus placebo

Group Type EXPERIMENTAL

Aliskiren plus placebo

Intervention Type DRUG

3

Various sequences of different doses of Aliskiren

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

4

Various sequences of different doses of Aliskiren plus placebo

Group Type EXPERIMENTAL

Aliskiren plus placebo

Intervention Type DRUG

Interventions

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Aliskiren

Intervention Type DRUG

Aliskiren plus placebo

Intervention Type DRUG

Aliskiren

Intervention Type DRUG

Aliskiren plus placebo

Intervention Type DRUG

Other Intervention Names

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SPP100 SPP100

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative site

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Fisher ND, Jan Danser AH, Nussberger J, Dole WP, Hollenberg NK. Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans. Circulation. 2008 Jun 24;117(25):3199-205. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.

Reference Type DERIVED
PMID: 18559696 (View on PubMed)

Other Identifiers

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CSPP100A2318

Identifier Type: -

Identifier Source: org_study_id