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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Aliskiren plus placebo

• Registration Number: NCT00518765
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-21
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-05
• Last Update Posted: 2010-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Aliskiren	Various sequences of different doses of Aliskiren
2	Aliskiren plus placebo	Various sequences of different doses of Aliskiren plus placebo
3	Aliskiren	Various sequences of different doses of Aliskiren
4	Aliskiren plus placebo	Various sequences of different doses of Aliskiren plus placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States