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Diurnal Variation of Plasminogen Activator Inhibitor-1

NCT00515021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-02-01

Study results available
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Summary

To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.

Conditions

  • Metabolic Syndrome X

Interventions

DRUG

Eplerenone (Morning)

Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg. 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks.

DRUG

Eplerenone (Night-time)

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • James A Muldowney, III, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515021 on ClinicalTrials.gov