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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aliskiren

Aliskiren plus placebo

Aliskiren

Aliskiren plus placebo

About this trial

This is an interventional basic science trial for Hypertension focused on measuring aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Various sequences of different doses of Aliskiren

Various sequences of different doses of Aliskiren plus placebo

Various sequences of different doses of Aliskiren

Various sequences of different doses of Aliskiren plus placebo

Outcomes

Primary Outcome Measures

Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet

Secondary Outcome Measures

Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway

Full Information

NCT ID

NCT00518765

First Posted

August 20, 2007

Last Updated

October 5, 2010

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00518765

Brief Title

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

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"

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Various sequences of different doses of Aliskiren

Arm Title

Arm Type

Experimental

Arm Description

Various sequences of different doses of Aliskiren plus placebo

Arm Title

Arm Type

Experimental

Arm Description

Various sequences of different doses of Aliskiren

Arm Title

Arm Type

Experimental

Arm Description

Various sequences of different doses of Aliskiren plus placebo

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Other Intervention Name(s)

SPP100

Intervention Type

Drug

Intervention Name(s)

Aliskiren plus placebo

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Other Intervention Name(s)

SPP100

Intervention Type

Drug

Intervention Name(s)

Aliskiren plus placebo

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Investigative site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18559696

Citation

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.

Results Reference

derived

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

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