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Studies on Aldosterone and Vascular Function

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00700479
First received: December 25, 2007
Last updated: June 17, 2008
Last verified: June 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Studies on Aldosterone and Vascular Function

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects age >18 years

Exclusion Criteria:

  • Any chronic medical disease or chronic use of medications
  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Yale University:
vascular endothelium
nitric oxide
aldosterone
vascular biology

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014