MedDataX Logo

Studies on Aldosterone and Vascular Function

NCT ID: NCT00700479

Last Updated: 2008-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

vascular endothelium nitric oxide aldosterone vascular biology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Aldosterone plus low salt diet

Group Type EXPERIMENTAL

aldosterone

Intervention Type DRUG

4 hour infusion

low or high sodium diet

Intervention Type DIETARY_SUPPLEMENT

B

Aldosterone plus high sodium diet

Group Type EXPERIMENTAL

aldosterone

Intervention Type DRUG

4 hour infusion

low or high sodium diet

Intervention Type DIETARY_SUPPLEMENT

C

Placebo plus low sodium diet

Group Type PLACEBO_COMPARATOR

low or high sodium diet

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DRUG

placebo

D

placebo plus high sodium diet

Group Type PLACEBO_COMPARATOR

low or high sodium diet

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aldosterone

4 hour infusion

Intervention Type DRUG

low or high sodium diet

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy subjects age \>18 years

Exclusion Criteria

* Any chronic medical disease or chronic use of medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yale School of Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stuart Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

602001143

Identifier Type: -

Identifier Source: org_study_id