Studies on Aldosterone and Vascular Function - Full Text View

Sponsors and Collaborators:	Yale University Pfizer
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00700479

Purpose

A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.

Condition	Intervention	Phase
Inflammation	Drug: aldosterone Dietary Supplement: low or high sodium diet Drug: placebo	Phase I

Drug Information available for: Nitric oxide Aldosterone

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Studies on Aldosterone and Vascular Function

Further study details as provided by Yale University:

Primary Outcome Measures:

Flow mediated dilation brachial artery [ Time Frame: 0 and 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Aldosterone plus low salt diet	Drug: aldosterone 4 hour infusion Dietary Supplement: low or high sodium diet
B: Experimental Aldosterone plus high sodium diet	Drug: aldosterone 4 hour infusion Dietary Supplement: low or high sodium diet
C: Placebo Comparator Placebo plus low sodium diet	Dietary Supplement: low or high sodium diet Drug: placebo placebo
D: Placebo Comparator placebo plus high sodium diet	Dietary Supplement: low or high sodium diet Drug: placebo placebo

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700479

Locations

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

Pfizer

Investigators

Principal Investigator:

Stuart Katz, MD

Yale School of Medicine

More Information

Responsible Party:	Yale School of Medicine ( Stuart Katz )
Study ID Numbers:	602001143
Study First Received:	December 25, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00700479
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

vascular endothelium
nitric oxide
aldosterone
vascular biology

Study placed in the following topic categories:

Nitric Oxide
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009