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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518765
First Posted: August 21, 2007
Last Update Posted: October 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Hypertension Drug: Aliskiren Drug: Aliskiren plus placebo Phase 3

Novartis has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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"

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 32
Study Start Date: October 2005
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Various sequences of different doses of Aliskiren
Drug: Aliskiren
Other Name: SPP100
Experimental: 2
Various sequences of different doses of Aliskiren plus placebo
Drug: Aliskiren plus placebo
Experimental: 3
Various sequences of different doses of Aliskiren
Drug: Aliskiren
Other Name: SPP100
Experimental: 4
Various sequences of different doses of Aliskiren plus placebo
Drug: Aliskiren plus placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518765


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00518765     History of Changes
Other Study ID Numbers: CSPP100A2318
First Submitted: August 20, 2007
First Posted: August 21, 2007
Last Update Posted: October 6, 2010
Last Verified: October 2010

Keywords provided by Novartis:
aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers

Additional relevant MeSH terms:
Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents